FDA Review Panel · CH

FDA 510(k) Chemistry Devices

FDA 510(k) Chemistry Devices - Regulatory Overview

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.

13237
Total
13205
Cleared
191d
Avg (2y)
1976
Since
11173 Chemistry devices
401–425 of 11173
Cleared Apr 14, 2020
Stat Profile Prime Plus Analyzer System
K200403 · Nova Biomedical Corporation
JGS · Electrode, Ion Specific, Sodium · 55d
Cleared Apr 09, 2020
i-STAT CG4+ Cartridge with the i-STAT 1 System
K200492 · Abbott Point of Care, Inc.
CHL · Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph · 41d
Cleared Apr 07, 2020
BlueStar Rx
K193654 · Welldoc, Inc.
MRZ · Accessories, Pump, Infusion · 99d
Cleared Apr 06, 2020
Stat Profile Prime Plus Analyzer System
K200204 · Nova Biomedical Corporation
GGZ · Oxyhemoglobin · 69d
Cleared Mar 27, 2020
RAPIDPoint 500e Blood Gas System
K192240 · Siemens Healthcare Diagnostics, Inc.
CHL · Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph · 221d
Cleared Mar 26, 2020
Tina-quant Hemoglobin A1cDx Gen.3
K193053 · Roche Diagnostics Operations (Rdo)
PDJ · Hemoglobin A1c Test System · 146d
Cleared Mar 26, 2020
Aina HbA1c Monitoring System 2
K192987 · Jana Care, Inc.
LCP · Assay, Glycosylated Hemoglobin · 153d
Cleared Mar 20, 2020
Bioland Blood Glucose Monitoring System
K191657 · Bioland Technology, Ltd.
NBW · System, Test, Blood Glucose, Over The Counter · 273d
Cleared Mar 17, 2020
EndoTool IV 1.10
K200443 · Monarch Medical Technologies, LLC
NDC · Calculator, Drug Dose · 22d
Cleared Mar 13, 2020
Stat Profile Prime Plus Analyzer System
K200349 · Nova Biomedical Corporation
CGA · Glucose Oxidase, Glucose · 30d
Cleared Feb 28, 2020
Basal-IQ Technology
K193483 · Tandem Diabetes Care, Inc.
QJS · Interoperable Automated Glycemic Controller, Insulin Suspend · 73d
Cleared Feb 27, 2020
Proov Test
K191462 · Mfb Fertility, Inc.
QKE · Immunoassay, Pregnanediol Glucuronide, Over The Counter · 269d
Cleared Feb 18, 2020
InPen Dose Calculator
K190487 · Companion Medical, Inc.
NDC · Calculator, Drug Dose · 355d
Cleared Feb 14, 2020
OneTouch Verio Reflect Blood Glucose Monitoring System
K193475 · Lifescan Europe GmbH
NBW · System, Test, Blood Glucose, Over The Counter · 60d
Cleared Feb 14, 2020
i-STAT CHEM8+ cartridge with the i-STAT 1 System
K191360 · Abbott Point of Care, Inc.
JFP · Electrode, Ion Specific, Calcium · 269d
Cleared Feb 07, 2020
NeoBase 2 Non-derivatized MSMS Kit
K193103 · Perkinelmer, Inc.
NQL · System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry · 91d
Cleared Feb 07, 2020
i-STAT CHEM8+ cartridge with the i-STAT 1 System
K191298 · Abbott Point of Care, Inc.
JFL · Ph Rate Measurement, Carbon-dioxide · 269d
Cleared Feb 07, 2020
i-STAT CHEM8+ cartridge with the i-STAT 1 System
K183688 · Abbott Point of Care, Inc.
JGS · Electrode, Ion Specific, Sodium · 406d
Cleared Feb 07, 2020
i-STAT CHEM8+ cartridge with the i-STAT 1 System
K183678 · Abbott Point of Care, Inc.
CGA · Glucose Oxidase, Glucose · 406d
Cleared Feb 05, 2020
OptiScanner® 5000 Glucose Monitoring System
K192785 · Optiscan Biomedical Corporation
LZF · Pump, Infusion, Analytical Sampling · 128d
Cleared Jan 29, 2020
Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System
K193642 · Dexcom, Inc.
QDK · Integrated Continuous Glucose Monitoring System For Non-intensive Diabetes Management · 30d
Cleared Jan 24, 2020
Stat Profile Prime Plus Analyzer System
K193246 · Nova Biomedical Corporation
CHL · Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph · 60d
Cleared Jan 24, 2020
CareSens S Clear BT Blood Glucose Monitoring System
K192859 · I-Sens, Inc.
NBW · System, Test, Blood Glucose, Over The Counter · 112d
Cleared Jan 17, 2020
CareSens S Fit BT Blood Glucose Monitoring System
K193590 · I-Sens, Inc.
NBW · System, Test, Blood Glucose, Over The Counter · 25d
Cleared Jan 17, 2020
MAGLUMI 2000 HCG/ß-HCG
K192547 · Shenzhen New Industries Biomedical Engineering Co., Ltd.
DHA · System, Test, Human Chorionic Gonadotropin · 122d

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 11173 JJY Multi-analyte Controls, All Kinds (assayed) 491 NBW System, Test, Blood Glucose, Over The Counter 453 JJX Single (specified) Analyte Controls (assayed And Unassayed) 382 CGA Glucose Oxidase, Glucose 297 JHI Visual, Pregnancy Hcg, Prescription Use 285 JIX Calibrator, Multi-analyte Mixture 246 CIG Diazo Colorimetry, Bilirubin 216 JIT Calibrator, Secondary 199 JLW Radioimmunoassay, Thyroid-stimulating Hormone 188 CHH Enzymatic Esterase--oxidase, Cholesterol 186 LCX Kit, Test, Pregnancy, Hcg, Over The Counter 175 CHL Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph 156 JJE Analyzer, Chemistry (photometric, Discrete), For Clinical Use 153 JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use 147 CGX Alkaline Picrate, Colorimetry, Creatinine 143