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
191d
Avg (2y)
1976
Since
11192 Chemistry devices
Cleared
Mar 07, 2011
ADVIA CHEMISTRY GLUCOSE HEXOKINASE_3 (GLUH_3) REAGENT, MODELS REF 05001429
CFR
Hexokinase, Glucose
249d
Cleared
Mar 01, 2011
RANDOX ECSTASY (MDMA) ASSAY
DKZ
Enzyme Immunoassay, Amphetamine
581d
Cleared
Feb 17, 2011
TECO DIAGNOSTICS UTI DETECTION STRIPS
JMT
Diazo (colorimetric), Nitrite (urinary, Non-quant)
408d
Cleared
Feb 16, 2011
ENZYME II CALIBRATOR
JIT
Calibrator, Secondary
48d
Cleared
Feb 15, 2011
AFINION ANALYZER
LCP
Assay, Glycosylated Hemoglobin
36d
Cleared
Feb 11, 2011
ROCHE ORAL FLUID COCAINE
DIO
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
291d
Cleared
Feb 11, 2011
THERMO SCIENTIFIC QMS EVEROLIMUS REAGENTS, CALIBRATORS AND CONTROLS
OUF
Everolimus Immunoassay
388d
Cleared
Feb 11, 2011
ROCHE ORAL FLUID OPIATES, DAT QUAL CAL A, DAT CONTROL SET A AND DAT SQ CAL A
DJG
Enzyme Immunoassay, Opiates
402d
Cleared
Feb 11, 2011
ONE TOUCH VERIO BLOOD GLUCOSE MONITORING SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
434d
Cleared
Feb 10, 2011
LIFESCAN ONETOUCH SELECT / ULTRA / VITA GLUCOSE CONTROL SOLUTION
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
69d
Cleared
Feb 08, 2011
I-STAT 1 WIRELESS ANALYZER
CGA
Glucose Oxidase, Glucose
102d
Cleared
Feb 04, 2011
MULTICONSTITUENT CALIBRATOR
JIX
Calibrator, Multi-analyte Mixture
77d
Cleared
Feb 04, 2011
URITEK TC-101 URINE ANALYZER, URINE REAGENT STRIPS 10, MODELS TC-101, URS-10
JIL
Method, Enzymatic, Glucose (urinary, Non-quantitative)
234d
Cleared
Feb 02, 2011
MISSION LIQUID URINE CONTROL, MISSION LIQUID DIPTUBE URINE CONTROL, MISSION DRY STRIP URINE CONTROL
JJW
Urinalysis Controls (assayed And Unassayed)
76d
Cleared
Jan 25, 2011
DIMENSION VISA ENZ 2 CAL
JIX
Calibrator, Multi-analyte Mixture
47d
Cleared
Jan 25, 2011
FDI GLUCOSE CONTROL SOLUTION FOR FREESTYLE
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
62d
Cleared
Jan 25, 2011
MSC LIPID CONTROL
JJY
Multi-analyte Controls, All Kinds (assayed)
81d
Cleared
Jan 25, 2011
ORAL FLUID PHENCYCLIDINE
LCM
Enzyme Immunoassay, Phencyclidine
397d
Cleared
Jan 20, 2011
ELECYSYS SHBG
CDZ
Radioimmunoassay, Testosterones And Dihydrotestosterone
114d
Cleared
Jan 14, 2011
PROLYTE ELECTROLYTE ANALYZER
JGS
Electrode, Ion Specific, Sodium
101d
Cleared
Jan 14, 2011
DIAZYME 25-HYDROXY VITAMIN D ASSAY KIT MODEL DZ688A, DIAZYME 25-HYDROXY VITAMIN D ASSAY CALIBRATOR SET MODEL DZ688A-CAL,
MRG
System, Test, Vitamin D
141d
Cleared
Jan 14, 2011
AUDIT MICROCV PROTEIN LINEARITY SET
JJY
Multi-analyte Controls, All Kinds (assayed)
259d
Cleared
Jan 14, 2011
EASYRA SODIUM ASSAY, EASYRA POTASSIUM ASSAY, EASYRA CHLORIDE ASSAY, EASYRA CARBON DIOXIDE ASSAY MODEL CAT NO. 5423 & 520
JGS
Electrode, Ion Specific, Sodium
296d
Cleared
Jan 10, 2011
AUDIT MICROCV CARDIAC MARKERS LINEARITY SET
JJY
Multi-analyte Controls, All Kinds (assayed)
122d
Cleared
Jan 07, 2011
ELECSYS DHEA-S CALCHECK 5
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
49d
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