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
Aug 09, 2011
CYBOW READER, MODELS 300 & 720
KQO
Automated Urinalysis System
371d
Cleared
Aug 09, 2011
BLOOD GLUCOSE MONITORING SYSTEM, MODELS AG-6081 AND AG-6951
NBW
System, Test, Blood Glucose, Over The Counter
456d
Cleared
Aug 05, 2011
ST AIA-PACK DHEA-S CALIBRATOR SET
JIT
Calibrator, Secondary
43d
Cleared
Aug 03, 2011
ATLAS HOME PREGNANCY TEST (MIDSTREAM FORMAT) MODEL 70172001
LCX
Kit, Test, Pregnancy, Hcg, Over The Counter
314d
Cleared
Jul 28, 2011
TELCARE BLOOD GLUCOSE MONITORING SYSTEM, TEST STRIPS, CONTROL SOLUTIONS, TELSERVE-HOME USE, TELSERVE-PROFESSIONAL USE
NBW
System, Test, Blood Glucose, Over The Counter
149d
Cleared
Jul 28, 2011
PREGNANCY ONE STEP RAPID TEST
LCX
Kit, Test, Pregnancy, Hcg, Over The Counter
234d
Cleared
Jul 21, 2011
ELECSYS T3 CALCHECK 5
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
48d
Cleared
Jul 20, 2011
AVIE A1C TEST SYSTEM
LCP
Assay, Glycosylated Hemoglobin
610d
Cleared
Jul 19, 2011
ABL90
CHL
Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph
14d
Cleared
Jul 15, 2011
WONDFO AMPHETAMINE URINE TEST, WONDFO BARBITURATES URINE TEST, WONDFO BENZODIAZEPINES URINE TEST
DKZ
Enzyme Immunoassay, Amphetamine
42d
Cleared
Jul 15, 2011
OPIATE ENZYME IMMUNOASSAY
DJG
Enzyme Immunoassay, Opiates
164d
Cleared
Jul 15, 2011
SPOTCHECK NEONATAL GALT MICROPLATE REAGENT KIT
KQP
Fluorescent Proc. (qual.), Galactose-1-phosphate Uridyl Transferase
304d
Cleared
Jul 15, 2011
AG-695 SINGLE AND MULTI BLOOD GLUCOSE MONITORING SYSTEM/AG-696 SINGLE AND MULTI BLOOD GLUCOSE MONITORING SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
585d
Cleared
Jul 13, 2011
EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATOR
DCF
Albumin, Antigen, Antiserum, Control
450d
Cleared
Jul 12, 2011
EASYRA HDL REAGENT
LBS
Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl
89d
Cleared
Jul 08, 2011
ELECSYS PRECICONTROL VARIA 3
JJY
Multi-analyte Controls, All Kinds (assayed)
37d
Cleared
Jul 06, 2011
FORA POCT S10/TD-4258 BLOOD GLUCOSE MONITORING SYSTEM
LFR
Glucose Dehydrogenase, Glucose
673d
Cleared
Jul 05, 2011
VALIDATE (R) GC3 CALIBRATION VERIFICATION / LINEARITY TEST KIT
JJY
Multi-analyte Controls, All Kinds (assayed)
97d
Cleared
Jul 01, 2011
FORA POCT MANAGMENT SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
79d
Cleared
Jun 29, 2011
THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PRO
JJY
Multi-analyte Controls, All Kinds (assayed)
118d
Cleared
Jun 28, 2011
VITAL SERUM CONTROLS
JJY
Multi-analyte Controls, All Kinds (assayed)
71d
Cleared
Jun 28, 2011
INDIKO
JJE
Analyzer, Chemistry (photometric, Discrete), For Clinical Use
174d
Cleared
Jun 27, 2011
U-RIGHT TD-4279 BLOOD GLUCOSE MONITORING SYSTEM, FORA GD40/TD-4272 BLOOD GLUCOSE MONITORING SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
391d
Cleared
Jun 23, 2011
LZI CANNABINOIDS (CTHC) HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS, CONTROL
LDJ
Enzyme Immunoassay, Cannabinoids
148d
Cleared
Jun 21, 2011
ELITECH CLINICAL SYSTEMS CALCIUM ARSENAZO
CIX
Bromcresol Green Dye-binding, Albumin
88d
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