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
11219 Chemistry devices
3251–3275 of 11219
Cleared Jul 05, 2000
DADE TRU-LIQUID MONI-TROL CHEMISTRY CONTROL LEVELS 1, MID, 2, AND S (ASSAYED)
K001758 · Medical Analysis Systems, Inc.
JJY · Multi-analyte Controls, All Kinds (assayed) · 26d
Cleared Jul 03, 2000
EZ LDL CHOLESTEROL TEST SYSTEM
K993741 · Sigma Diagnostics, Inc.
MRR · System, Test, Low Density, Lipoprotein · 242d
Cleared Jul 03, 2000
BIOSCANNER TRIGLYCERIDES TEST STRIPS
K000586 · Polymer Technology Systems, Inc.
JGY · Colorimetric Method, Triglycerides · 132d
Cleared Jun 29, 2000
SUGAR CHEX ONE
K001443 · Streck Laboratories, Inc.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 52d
Cleared Jun 28, 2000
ELECSYS INSULIN CALCHECK
K001846 · Roche Diagnostics Corp.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 9d
Cleared Jun 28, 2000
VITROS CHEMISTRY PRODUCTS AST SLIDE AND CHEMISTRY PRODUCTS CALIBRATOR KIT 3
K001679 · Ortho-Clinical Diagnostics, Inc.
CIT · Nadh Oxidation/nad Reduction, Ast/sgot · 27d
Cleared Jun 26, 2000
INFINITY AMYLASE REAGENT (PROCEDURE NO. 580/568)
K001569 · Sigma Diagnostics, Inc.
JFJ · Catalytic Methods, Amylase · 38d
Cleared Jun 26, 2000
ADVIA IMS
K001344 · Bayer Corp.
DIH · Colorimetry, Cholinesterase · 60d
Cleared Jun 22, 2000
DBEST HCG 2 IU/ML TEST KIT
K001215 · Ameritek, Inc.
JHI · Visual, Pregnancy Hcg, Prescription Use · 69d
Cleared Jun 21, 2000
VITROS CHEMISTRY PRODUCTS CREA DT SLIDES
K001769 · Ortho-Clinical Diagnostics
CGX · Alkaline Picrate, Colorimetry, Creatinine · 9d
Cleared Jun 19, 2000
OPTI-CHECK PLUS MULTI-ANALYTE CONTROL, MODEL HC7009
K001632 · Avl Scientific Corp.
JJY · Multi-analyte Controls, All Kinds (assayed) · 24d
Cleared Jun 19, 2000
CALIBRATION SOLUTION 1, MODEL A943-837
K001484 · Alko Diagnostic Corp.
JIX · Calibrator, Multi-analyte Mixture · 39d
Cleared Jun 09, 2000
DELFIA NEONATAL IRT KIT
K993697 · Wallac OY
CGZ · Electrode, Ion-specific, Chloride · 220d
Cleared Jun 02, 2000
SYNCHRON CONTROL
K001458 · Beckman Coulter, Inc.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 23d
Cleared Jun 02, 2000
AMMONIA-L3K ASSAY, MODEL 263-17, AMMONIA-L3K ASSAY, MODEL 263-30
K001285 · Diagnostic Chemicals , Ltd.
JIF · Enzymatic Method, Ammonia · 42d
Cleared Jun 01, 2000
WAKO HDL-C/LDL-C CALIBRATOR
K001005 · Wako Chemicals USA, Inc.
JIS · Calibrator, Primary · 64d
Cleared Jun 01, 2000
WAKO APOLIPOPROTEIN HIGH LEVEL CALIBRATOR
K001004 · Wako Chemicals USA, Inc.
JIS · Calibrator, Primary · 64d
Cleared May 25, 2000
LIQUICHEK IMMUNOASSAY PLUS CONTROL, MODEL 360, 361, 362, 363
K001373 · Bio-Rad
JJY · Multi-analyte Controls, All Kinds (assayed) · 24d
Cleared May 24, 2000
BIOSCANNER TRIGLYCERIDES TEST STRIPS
K991894 · Polymer Technology Systems, Inc.
JGY · Colorimetric Method, Triglycerides · 356d
Cleared May 24, 2000
WAKO LIPASE CALIBRATOR
K001002 · Wako Chemicals USA, Inc.
JIS · Calibrator, Primary · 56d
Cleared May 18, 2000
BAYER ADVIA IMS SYSTEM
K000921 · Bayer Corp.
DER · Alpha-1-lipoprotein, Antigen, Antiserum, Control · 57d
Cleared May 18, 2000
ADDITIONAL ASSAYS FOR BAYER ADVIA IMS SYSTEM
K000903 · Bayer Corp.
KLT · Enzyme Immunoassay, Carbamazepine · 58d
Cleared May 18, 2000
THE CARDIAC READER SYSTEM
K000784 · Roche Diagnostics Corp.
MMI · Immunoassay Method, Troponin Subunit · 69d
Cleared May 17, 2000
IMMAGE IMMUNOCHEMISTRY SYSTEM LIPOPROTEIN(A) LPAX REAGENT, ARRAY SYSTEM LIPOPROTEIN(A) LPA REAGENT, LIPOPROTEIN(A) CALIB
K000121 · Beckman Coulter, Inc.
DFC · Lipoprotein, Low-density, Antigen, Antiserum, Control · 120d
Cleared May 15, 2000
BVBLUE
K993732 · Gryphus Diagnostics, LLC
MXB · Test, Vaginal, Bacterial Sialidase · 193d

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 11219 JJY Multi-analyte Controls, All Kinds (assayed) 491 NBW System, Test, Blood Glucose, Over The Counter 462 JJX Single (specified) Analyte Controls (assayed And Unassayed) 384 CGA Glucose Oxidase, Glucose 300 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