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
201–225 of 264
Cleared May 15, 2023
Dexcom G7 Continuous Glucose Monitoring (CGM) System
K231081 · Dexcom, Inc.
QBJ · Integrated Continuous Glucose Monitoring System, Factory Calibrated · 28d
Cleared Apr 24, 2023
Omnipod GO Insulin Delivery Device
K223372 · Insulet Corporation
LZG · Pump, Infusion, Insulin · 171d
Cleared Apr 13, 2023
FreeStyle Libre 3 Continuous Glucose Monitoring System
K223435 · Abbott Diabetes Care, Inc.
QBJ · Integrated Continuous Glucose Monitoring System, Factory Calibrated · 150d
Cleared Apr 13, 2023
AUTION MAX AX-4060 Urinalysis System
K193514 · Arkray, Inc.
JIL · Method, Enzymatic, Glucose (urinary, Non-quantitative) · 1211d
Cleared Apr 07, 2023
Elecsys FT4 IV
K220456 · Roche Diagnostics
CEC · Radioimmunoassay, Free Thyroxine · 414d
Cleared Mar 30, 2023
ONLINE TDM Phenytoin - Free Phenytoin application
K230161 · Roche Diagnostics
MOJ · Fluorescence Polarization Immunoassay, Diphenylhydantoin (free) · 69d
Cleared Mar 20, 2023
Atellica® CH Diazo Total Bilirubin (D_TBil)
K222104 · Siemens Healthcare Diagnostics, Inc.
CIG · Diazo Colorimetry, Bilirubin · 245d
Cleared Mar 03, 2023
FreeStyle Libre 2 Flash Glucose Monitoring System
K222447 · Abbott Diabetes Care, Inc.
QBJ · Integrated Continuous Glucose Monitoring System, Factory Calibrated · 200d
Cleared Feb 21, 2023
FreeStyle Libre 2 System, FreeStyle Libre 3 System
K223537 · Abbott Diabetes Care, Inc.
QLG · Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems · 90d
Cleared Feb 08, 2023
Access Cortisol
K223038 · Beckman Coulter, Inc.
CGR · Radioimmunoassay, Cortisol · 132d
Cleared Feb 03, 2023
Access AMH
K223679 · Beckman Coulter, Inc.
PQO · Anti-müllerian Hormone Test System · 57d
Cleared Jan 27, 2023
GEM Premier ChemSTAT
K223090 · Instrumentation Laboratory CO
CGA · Glucose Oxidase, Glucose · 119d
Cleared Jan 19, 2023
Access 25(OH) Vitamin D Total
K223503 · Beckman Coulter, Inc.
MRG · System, Test, Vitamin D · 58d
Cleared Jan 13, 2023
Access Testosterone
K223405 · Beckman Coulter, Inc.
CDZ · Radioimmunoassay, Testosterones And Dihydrotestosterone · 65d
Cleared Jan 11, 2023
Dexcom G6 Continuous Glucose Monitoring (CGM) System
K223931 · Dexcom, Inc.
QBJ · Integrated Continuous Glucose Monitoring System, Factory Calibrated · 12d
Cleared Dec 27, 2022
Access Total ßhCG (5th IS)
K221990 · Beckman Coulter, Inc.
DHA · System, Test, Human Chorionic Gonadotropin · 174d
Cleared Dec 23, 2022
Access Vitamin B12
K223289 · Beckman Coulter, Inc.
CDD · Radioassay, Vitamin B12 · 59d
Cleared Dec 21, 2022
GlucoSure ADVANCE Link Blood Glucose Monitoring System
K222234 · Apex BioTechnology Corp.
NBW · System, Test, Blood Glucose, Over The Counter · 148d
Cleared Dec 07, 2022
Dexcom G7 Continuous Glucose Monitoring System
K213919 · Dexcom, Inc.
QBJ · Integrated Continuous Glucose Monitoring System, Factory Calibrated · 357d
Cleared Nov 10, 2022
Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer
K221225 · Beckman Coulter, Inc.
JLW · Radioimmunoassay, Thyroid-stimulating Hormone · 196d
Cleared Nov 04, 2022
BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring System
K220421 · Apex BioTechnology Corp.
NBW · System, Test, Blood Glucose, Over The Counter · 263d
Cleared Oct 18, 2022
Nova Primary Glucose Analyzer System
K203549 · Nova Biomedical Corporation
CGA · Glucose Oxidase, Glucose · 683d
Cleared Sep 16, 2022
cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSH
K220134 · Roche Diagnostics
CFR · Hexokinase, Glucose · 241d
Cleared Aug 25, 2022
GlucoSure Link Blood Glucose Monitoring System
K212140 · Apex BioTechnology Corp.
NBW · System, Test, Blood Glucose, Over The Counter · 413d
Cleared Aug 19, 2022
SmartBolus Calculator
K222239 · Insulet Corporation
QRX · Continuous Glucose Monitor Informed Insulin Dose Calculator · 24d

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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 JLW Radioimmunoassay, Thyroid-stimulating Hormone 6 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