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
181d
Avg (2y)
1976
Since
11231 Chemistry devices
4251–4275 of 11231
Cleared Feb 10, 1997
GLUCOMETER ELITE BLOOD GLUCOSE METER
K964630 · Bayer Corp.
CGA · Glucose Oxidase, Glucose · 83d
Cleared Feb 10, 1997
TROPONIN-I TEST SYSTEM
K964862 · Dade Intl., Inc.
MMI · Immunoassay Method, Troponin Subunit · 68d
Cleared Feb 10, 1997
VACUTAINER BRAND SAFETY-LOK BLOOD COLLECTION SET
K965202 · Bd Becton Dickinson Vacutainer Systems Preanalytic
JKA · Tubes, Vials, Systems, Serum Separators, Blood Collection · 46d
Cleared Feb 10, 1997
ELECSYS CALCHECK PROLACTIN
K970147 · Boehringer Mannheim Corp.
JJY · Multi-analyte Controls, All Kinds (assayed) · 26d
Cleared Feb 10, 1997
ELECSYS CALCHECK ESTRADIOL
K970148 · Boehringer Mannheim Corp.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 26d
Cleared Feb 07, 1997
FEMEXAM TESTCARD
K962718 · Litmus Concepts, Inc.
CEN · Dye-indicator, Ph (urinary, Non-quantitative) · 210d
Cleared Feb 06, 1997
STABLELIN ENZYME LINEARITY TEST SET C (ITEM NO. 003)
K965169 · Specialized Assays, Inc.
JJT · Enzyme Controls (assayed And Unassayed) · 44d
Cleared Feb 06, 1997
HCG CONTROLS
K970176 · International Newtech Development, Inc.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 20d
Cleared Feb 04, 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM TDM (CAR,PHE,PHY, & THE) REAGENTS
K963673 · Beckman Instruments, Inc.
KLT · Enzyme Immunoassay, Carbamazepine · 144d
Cleared Feb 04, 1997
VITROS IMMUNODIAGNOSTICS PRODUCTS FSH REAGENT PACK (GEM. 1005) FSH CALIBRATORS (GEM.C005)
K964720 · Johnson & Johnson Clinical Diagnostics, Inc.
CGJ · Radioimmunoassay, Follicle-stimulating Hormone · 71d
Cleared Feb 04, 1997
ALKALINE PHOSPHATASE
K964914 · Derma Media Lab., Inc.
CJE · Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes · 57d
Cleared Feb 04, 1997
STABLELIN ENZYME LINERARITY TEST SET A (ITEM NO. 001)
K965166 · Specialized Assays, Inc.
JJT · Enzyme Controls (assayed And Unassayed) · 42d
Cleared Feb 04, 1997
STABLELIN ENZYME LINEARITY TEST SET B (ITEM NO. 002)
K965168 · Specialized Assays, Inc.
JJT · Enzyme Controls (assayed And Unassayed) · 42d
Cleared Feb 04, 1997
PERFECTA PREGNANCY TEST
K965184 · Wyntek Diagnostics, Inc.
LCX · Kit, Test, Pregnancy, Hcg, Over The Counter · 42d
Cleared Feb 04, 1997
OSOM CLASSIC HCG-URINE TEST (115)
K965227 · Wyntek Diagnostics, Inc.
JHI · Visual, Pregnancy Hcg, Prescription Use · 36d
Cleared Jan 30, 1997
VITROS IMMUNODIAGNOSITCS PRODUCTS-FREE T3 REAGENT PACK (GEM.1020)/FREE T3 CALIBRATORS (GEM.C020)
K970016 · Johnson & Johnson Clinical Diagnostics, Inc.
CDP · Radioimmunoassay, Total Triiodothyronine · 28d
Cleared Jan 30, 1997
ELECSYS CALCHECK TESTOSTERONE
K970146 · Boehringer Mannheim Corp.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 15d
Cleared Jan 27, 1997
VITROS IMMUNODDIAGNOSTICS PRODUCTS RE CONTROLS (GEM.5015)
K965048 · Johnson & Johnson Clinical Diagnostics, Inc.
JJY · Multi-analyte Controls, All Kinds (assayed) · 40d
Cleared Jan 24, 1997
MICRO H2
K963376 · Micro Direct, Inc.
NRH · System, Breath Measurement · 150d
Cleared Jan 24, 1997
FERR FLEX REAGENT CARTRIDGE
K963498 · Dade Chemistry Systems, Inc.
JMG · Radioimmunoassay (two-site Solid Phase), Ferritin · 143d
Cleared Jan 24, 1997
ELECSYS LH ASSAY
K964694 · Boehringer Mannheim Corp.
CEP · Radioimmunoassay, Luteinizing Hormone · 63d
Cleared Jan 24, 1997
OPUS BONE ALP
K964764 · Behring Diagnostics, Inc.
CIN · Electrophoretic Separation, Alkaline Phosphatase Isoenzymes · 58d
Cleared Jan 24, 1997
ABBOTT ADVISOR ONE-STEP PREGNANCY TEST
K970082 · Abbott Laboratories
LCX · Kit, Test, Pregnancy, Hcg, Over The Counter · 15d
Cleared Jan 22, 1997
HCL - 200 BIOCHEMISTRY ANALYZER
K964409 · Hcl Laboratory Systems, Inc.
JJF · Analyzer, Chemistry, Micro, For Clinical Use · 79d
Cleared Jan 22, 1997
SEALITE SCIENCES, INC. AQUALITE LH
K964925 · Sealite Sciences, Inc.
CEP · Radioimmunoassay, Luteinizing Hormone · 44d

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All categories 11231 JJY Multi-analyte Controls, All Kinds (assayed) 491 NBW System, Test, Blood Glucose, Over The Counter 467 JJX Single (specified) Analyte Controls (assayed And Unassayed) 385 CGA Glucose Oxidase, Glucose 301 JHI Visual, Pregnancy Hcg, Prescription Use 285 JIX Calibrator, Multi-analyte Mixture 248 CIG Diazo Colorimetry, Bilirubin 218 JIT Calibrator, Secondary 199 JLW Radioimmunoassay, Thyroid-stimulating Hormone 188 CHH Enzymatic Esterase--oxidase, Cholesterol 186 LCX Kit, Test, Pregnancy, Hcg, Over The Counter 176 CHL Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph 157 JJE Analyzer, Chemistry (photometric, Discrete), For Clinical Use 153 JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use 147 CGX Alkaline Picrate, Colorimetry, Creatinine 143