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.
13257
Total
13225
Cleared
177d
Avg (2y)
1976
Since
13257 Chemistry devices
Cleared
Jun 19, 2008
MULTIGENT CREATININE (ENZYMATIC) ASSAY
JFY
Enzymatic Method, Creatinine
176d
Cleared
Jun 13, 2008
ARKRAY GLUCOCARD 01 BLOOD MONITORING SYSTEM
CGA
Glucose Oxidase, Glucose
193d
Cleared
Jun 09, 2008
ONETOUCH ZOOM DIABETES MANAGEMENT PROGRAM
NBW
System, Test, Blood Glucose, Over The Counter
28d
Cleared
Jun 09, 2008
CLEVER CHEK TD-3250C BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
158d
Cleared
Jun 06, 2008
HUMAN CYSTATIN C KIT FOR USE ON MODULAR P ANALYSER
NDY
Test, Cystatin C
114d
Cleared
Jun 06, 2008
TRIAGE CARDIOPROFILER AND PROFILER S.O.B. PANELS
NBC
Test, Natriuretic Peptide
126d
Cleared
Jun 02, 2008
CLINIQA LIQUID QC COMPLETE CARDIAC MARKER CONTROL, LEVELS 1,2, AND 3
JJY
Multi-analyte Controls, All Kinds (assayed)
59d
Cleared
May 29, 2008
UREA/BUN, SCAL, NORTROL, ABTROL
CDQ
Urease And Glutamic Dehydrogenase, Urea Nitrogen
188d
Cleared
May 23, 2008
LOCI THYROID CALIBRATOR WITH MODEL RC610
JIX
Calibrator, Multi-analyte Mixture
35d
Cleared
May 23, 2008
DIMENSION TSHL FLEX REAGENT CARTRIDGE AND TSH SAMPLE DILUENT WITH MODELS RF 612 AND KD691
JLW
Radioimmunoassay, Thyroid-stimulating Hormone
37d
Cleared
May 23, 2008
DIRECT HBA1C, FRUCTOSAMINE, GLUCOSE OXIDASE LIQUID
LCP
Assay, Glycosylated Hemoglobin
79d
Cleared
May 23, 2008
URIC ACID (AOX), SCAL, NORTROL, ABTROL
JIX
Calibrator, Multi-analyte Mixture
154d
Cleared
May 16, 2008
DIMENSION VISTA N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE (PBNP) FLEX REAGENT CARTRIDGE (K6423A), DIMENSION VISTA
NBC
Test, Natriuretic Peptide
74d
Cleared
May 15, 2008
GENZYME CYSTATIN C REAGENT ANF GENZYME CYSTATIN C CALIBRATOR
NDY
Test, Cystatin C
66d
Cleared
May 12, 2008
CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) PROTEINS WITH MODEL 11355279160
JIX
Calibrator, Multi-analyte Mixture
69d
Cleared
May 08, 2008
TC MATRIX CLINICAL CHEMISTRY ANALYZER
JJE
Analyzer, Chemistry (photometric, Discrete), For Clinical Use
160d
Cleared
May 07, 2008
ESA BIOSCIENCES INC. VITAMIN D HPLC TEST
MRG
System, Test, Vitamin D
243d
Cleared
May 07, 2008
PROLYTE ELECTROLYTE ANALYZER
JGS
Electrode, Ion Specific, Sodium
483d
Cleared
Apr 24, 2008
ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLS
LPS
Urinary Homocystine (nonquantitative) Test System
120d
Cleared
Apr 21, 2008
SURECHEK EDGE BLOOD GLUCOSE MONITORING SYSTEM, MODEL SMS-4240
NBW
System, Test, Blood Glucose, Over The Counter
56d
Cleared
Apr 18, 2008
ONETOUCH ULTRALINK BLOOD GLUCOSE MONITORING SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
155d
Cleared
Apr 18, 2008
3TEST SUPREME GLUCOSE MONITORING SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
190d
Cleared
Apr 18, 2008
TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST SYSTEM
LCP
Assay, Glycosylated Hemoglobin
206d
Cleared
Apr 18, 2008
CREATINE KINASE LIQUID REAGENT, MODEL C519-440
CGS
Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes
221d
Cleared
Apr 14, 2008
HDL CHOLESTEROL REAGENT, MODEL 10211
LBS
Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl
123d
Looking for a specific chemistry device? Search by device name, K-number or manufacturer.
Search all Chemistry 510(k) devices