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
11222 Chemistry devices
3451–3475 of 11222
Cleared Jul 22, 1999
ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM
K991817 · Bayer Corp.
CIJ · Saccharogenic, Amylase · 56d
Cleared Jul 22, 1999
BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027
K991741 · Biocheck, Inc.
JHI · Visual, Pregnancy Hcg, Prescription Use · 62d
Cleared Jul 16, 1999
STAT PROFILE M7 ANALYZER
K991727 · Nova Biomedical Corp.
CGL · Electrode, Ion Based, Enzymatic, Creatinine · 57d
Cleared Jul 15, 1999
N PROTEIN STANDARD UY
K991705 · Dade Behring, Inc.
JIT · Calibrator, Secondary · 57d
Cleared Jul 13, 1999
ACE LDL-C REAGENT, LDL-C CALIBRATOR, LDL-C CONTROLS
K991733 · Schiapparelli Biosystems, Inc.
MRR · System, Test, Low Density, Lipoprotein · 53d
Cleared Jul 12, 1999
OSTEOMARK NTX POINT OF CARE (POC) CONTROL SET
K991917 · Metrika, Inc.
JJW · Urinalysis Controls (assayed And Unassayed) · 35d
Cleared Jul 09, 1999
ATAC-PAK DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS
K991789 · Elan Holdings, Inc.
LBR · Ldl & Vldl Precipitation, Hdl · 45d
Cleared Jul 09, 1999
SERUM CROSSLAPS ONE STEP ELISA
K990843 · Osteometer Biotech A/S
JMM · Column Chromatography & Color Development, Hydroxyproline · 116d
Cleared Jul 09, 1999
GLUCOMETER ELITE XL BLOOD GLUCOSE METER, GLUCOMETER ELITE BLOOD GLUCOSE TEST SYSTEMS
K990649 · Bayer Corp.
CGA · Glucose Oxidase, Glucose · 130d
Cleared Jul 09, 1999
PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM, PRECISION BLOOD GLUCOSE TEST STRIPS, PRECISION XTRA B-KETONE TEST ST
K983504 · Medisense, Inc.
CGA · Glucose Oxidase, Glucose · 276d
Cleared Jul 06, 1999
IMMULITE TURBO INTACT PTH, MODEL LSKPTZ
K992105 · Diagnostic Products Corp.
CEW · Radioimmunoassay, Parathyroid Hormone · 14d
Cleared Jul 01, 1999
OPUS TROPONIN I (CTN) TEST MODULES
K991177 · Dade Behring, Inc.
MMI · Immunoassay Method, Troponin Subunit · 85d
Cleared Jul 01, 1999
OPUS TROPONIN I CALIBRATOR
K991176 · Dade Behring, Inc.
JIT · Calibrator, Secondary · 85d
Cleared Jun 30, 1999
TIBC, PRODUCT NO'S 123-0, 123-02, FE109-01, FE109-02
K991666 · A.P. Total Care, Inc.
JMO · Ferrozine (colorimetric) Iron Binding Capacity · 47d
Cleared Jun 30, 1999
AST/SGOT
K991663 · A.P. Total Care, Inc.
CIT · Nadh Oxidation/nad Reduction, Ast/sgot · 47d
Cleared Jun 30, 1999
ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM
K991576 · Bayer Corp.
CIX · Bromcresol Green Dye-binding, Albumin · 55d
Cleared Jun 30, 1999
GLUCOMETER ELITE TEST STRIPS
K991242 · Bayer Corp.
CGA · Glucose Oxidase, Glucose · 79d
Cleared Jun 25, 1999
GREINER MINICOLLECT LITHIUM HEPARIN GEL BLOOD COLLECTION TUBE
K991843 · Greiner Meditech, Inc.
JKA · Tubes, Vials, Systems, Serum Separators, Blood Collection · 28d
Cleared Jun 25, 1999
N/T PROTEIN CONTROL LC
K991704 · Dade Behring, Inc.
JJY · Multi-analyte Controls, All Kinds (assayed) · 37d
Cleared Jun 24, 1999
MTM BIOSCANNER C TEST STRIPS
K990688 · Polymer Technology Systems, Inc.
CHH · Enzymatic Esterase--oxidase, Cholesterol · 119d
Cleared Jun 22, 1999
TSH ENZYME IMMUNOASSAY TEST KIT, MODEL #BC-1001
K991146 · Biocheck, Inc.
JLW · Radioimmunoassay, Thyroid-stimulating Hormone · 78d
Cleared Jun 22, 1999
BIOCHECK SENSITIVE TSH (S-TSH) ENZYME IMMUNOASSAY TEST KIT
K990993 · Biocheck, Inc.
JLW · Radioimmunoassay, Thyroid-stimulating Hormone · 90d
Cleared Jun 22, 1999
DADE BEHRING QUIKLYTE METABOLYTE CARTRIDGE, MODEL DIMENSION(R) XL OR RXL
K983344 · Dade Behring, Inc.
CGA · Glucose Oxidase, Glucose · 272d
Cleared Jun 21, 1999
QUANTASE TOTAL GALACTOSE SCREENING ASSAY 500 TEST KIT
K990654 · Quantase , Ltd.
JIA · Enzymatic Methods, Galactose · 112d
Cleared Jun 21, 1999
QUANTASE TOTAL GALACTOSE SCREENING ASSAY
K990644 · Quantase , Ltd.
JIA · Enzymatic Methods, Galactose · 115d

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All categories 11222 JJY Multi-analyte Controls, All Kinds (assayed) 491 NBW System, Test, Blood Glucose, Over The Counter 463 JJX Single (specified) Analyte Controls (assayed And Unassayed) 384 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