FDA Review Panel · CH

FDA 510(k) Chemistry Devices

About Chemistry Devices

FDA 510(k) chemistry devices cover in vitro diagnostic (IVD) instruments used in clinical laboratories. The FDA review panel code is CH.

This category includes:

  • Clinical chemistry analyzers - glucose, electrolytes, enzymes, proteins
  • Point-of-care test systems - rapid diagnostics for hospital and home use
  • Reagents and calibrators - consumables used with automated analyzers
  • Urinalysis systems - dipstick readers and urine sediment analyzers

Most devices in this panel are Class II (Special Controls) under 21 CFR Part 862. Data sourced from FDA 510(k) public files. Updated monthly.

13221
Total
13190
Cleared
88d
Avg days
1976
Since
264 Chemistry devices
151–175 of 264
Cleared Feb 23, 2024
StatStrip Glucose Hospital Meter System
K232075 · Nova Biomedical Corporation
PZI · Prescription Use Blood Glucose Meter For Near-patient Testing · 226d
Cleared Feb 23, 2024
CONTOUR® PLUS BLUE Blood Glucose Monitoring System
K231679 · Ascensia Diabetes Care
NBW · System, Test, Blood Glucose, Over The Counter · 259d
Cleared Feb 22, 2024
Vivatmo pro
K233775 · Bosch Healthcare Solutions GmbH
MXA · System, Test, Breath Nitric Oxide · 90d
Cleared Feb 16, 2024
Access CK-MB
K234005 · Beckman Coulter, Inc.
JHX · Fluorometric Method, Cpk Or Isoenzymes · 59d
Cleared Feb 08, 2024
Access SHBG
K233480 · Beckman Coulter, Inc.
CDZ · Radioimmunoassay, Testosterones And Dihydrotestosterone · 105d
Cleared Feb 05, 2024
FaStep™ Pregnancy Rapid Test Strip
K233174 · Assure Tech. (Hangzhou) Co, Ltd.
LCX · Kit, Test, Pregnancy, Hcg, Over The Counter · 130d
Cleared Feb 02, 2024
BD Vacutainer® K2 EDTA Blood Collection Tubes
K231373 · Becton, Dickinson and Company
JKA · Tubes, Vials, Systems, Serum Separators, Blood Collection · 266d
Cleared Jan 31, 2024
Clearblue® Early Detection Pregnancy Test
K240025 · Spd Swiss Precision Diagnostics GmbH
LCX · Kit, Test, Pregnancy, Hcg, Over The Counter · 28d
Cleared Jan 26, 2024
EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II
K232864 · Nantong Egens Biotechnology Co., Ltd.
LCX · Kit, Test, Pregnancy, Hcg, Over The Counter · 133d
Cleared Jan 19, 2024
BD Vacutainer® Fluoride Blood Collection Tubes
K231237 · Becton, Dickinson and Company
JKA · Tubes, Vials, Systems, Serum Separators, Blood Collection · 266d
Cleared Jan 19, 2024
RIGHTEST Blood Glucose Monitoring System Max Tel
K231192 · Bionime Corporation
NBW · System, Test, Blood Glucose, Over The Counter · 267d
Cleared Jan 18, 2024
CeQur Simplicity™ On-Demand Insulin Delivery System
K233447 · Cequr SA
OPP · Pump, Infusion, Insulin Bolus · 91d
Cleared Jan 18, 2024
Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2)
K233242 · Siemens Healthcare Diagnostics, Inc.
NQD · Cardiac C-reactive Protein, Antigen, Antiserum, And Control · 112d
Cleared Dec 20, 2023
BD Vacutainer® Serum Separator (SST™) Blood Collection Tubes
K230855 · Becton, Dickinson and Company
JKA · Tubes, Vials, Systems, Serum Separators, Blood Collection · 267d
Cleared Dec 18, 2023
Access hsTnI
K222881 · Beckman Coulter, Inc.
MMI · Immunoassay Method, Troponin Subunit · 452d
Cleared Dec 04, 2023
Access hsTnI
K230648 · Beckman Coulter, Inc.
MMI · Immunoassay Method, Troponin Subunit · 270d
Cleared Dec 01, 2023
BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™ Capillary Blood Collection Tube
K230391 · Becton, Dickinson and Company
JKA · Tubes, Vials, Systems, Serum Separators, Blood Collection · 290d
Cleared Nov 21, 2023
Quantisal™ Oral Fluid Collection Device
K232898 · Immunalysis Corporation
PJD · Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device · 64d
Cleared Nov 09, 2023
ARK Hydrocodone Assay
K231752 · ARK Diagnostics, Inc.
DJG · Enzyme Immunoassay, Opiates · 147d
Cleared Nov 03, 2023
Control-IQ Technology
K232382 · Tandem Diabetes Care, Inc.
QJI · Interoperable Automated Glycemic Controller · 87d
Cleared Nov 03, 2023
t:slim X2 Insulin Pump with Interoperable Technology
K232380 · Tandem Diabetes Care, Inc.
QFG · Alternate Controller Enabled Insulin Infusion Pump · 87d
Cleared Oct 27, 2023
i-STAT CG8+ cartridge with the i-STAT 1 System
K230300 · Abbott Point of Care, Inc.
JFP · Electrode, Ion Specific, Calcium · 266d
Cleared Oct 27, 2023
i-STAT CG8+ cartridge with the i-STAT 1 System
K230285 · Abbott Point of Care, Inc.
CHL · Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph · 267d
Cleared Oct 27, 2023
i-STAT CG8+ cartridge with the i-STAT 1 System
K230275 · Abbott Point of Care, Inc.
JGS · Electrode, Ion Specific, Sodium · 268d
Cleared Oct 18, 2023
Omnipod 5 ACE Pump
K231826 · Insulet Corporation
QFG · Alternate Controller Enabled Insulin Infusion Pump · 119d

Looking for a specific chemistry device? Search by device name, K-number or manufacturer.

Search all Chemistry 510(k) devices
Filter by Product Code
All categories 264 NBW System, Test, Blood Glucose, Over The Counter 20 QFG Alternate Controller Enabled Insulin Infusion Pump 19 LCX Kit, Test, Pregnancy, Hcg, Over The Counter 15 QJI Interoperable Automated Glycemic Controller 15 QBJ Integrated Continuous Glucose Monitoring System, Factory Calibrated 11 NBC Test, Natriuretic Peptide 9 MMI Immunoassay Method, Troponin Subunit 9 JKA Tubes, Vials, Systems, Serum Separators, Blood Collection 8 NDC Calculator, Drug Dose 7 CGA Glucose Oxidase, Glucose 7 CHL Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph 7 QLG Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems 6 DHA System, Test, Human Chorionic Gonadotropin 6 PDJ Hemoglobin A1c Test System 6 JLW Radioimmunoassay, Thyroid-stimulating Hormone 6