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
11197 Chemistry devices
Cleared
Jan 09, 2009
FORA TD-4245 BLOOD GLUCOSE MONITORING SYSTEM, TD-4245
CGA
Glucose Oxidase, Glucose
30d
Cleared
Dec 24, 2008
ENVISION BLOOD GLUCOSE TEST SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
161d
Cleared
Dec 22, 2008
VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 3600 IMMUNODIAGNOSTIC SYSTEM
JLW
Radioimmunoassay, Thyroid-stimulating Hormone
56d
Cleared
Dec 17, 2008
FORA TD-4244 & TD-4245 BLOOD GLUCOSE MONITORING SYSTESM
NBW
System, Test, Blood Glucose, Over The Counter
182d
Cleared
Dec 10, 2008
EASYRA BILIRUBIN DIRECT AND TOTAL REAGENT, PHOSPHORUS INORGANIC REAGENT AND IRON AND MAGNESIUM REAGENT
CIG
Diazo Colorimetry, Bilirubin
264d
Cleared
Dec 10, 2008
DIMENSION CLINICAL CHEMISTRY SYSTEM MPO FLEX REAGENT CARTRIDGE, CALIBRATOR,CONTROL, MODEL RF425, RC425,RC426
NTV
Myeloperoxidase, Immunoassay, System, Test
561d
Cleared
Dec 04, 2008
PRO GLUCOSE TEST STRIP
NBW
System, Test, Blood Glucose, Over The Counter
125d
Cleared
Dec 04, 2008
ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) FS
CIT
Nadh Oxidation/nad Reduction, Ast/sgot
286d
Cleared
Nov 26, 2008
RELION ULTIMA ADVANCE BLOOD GLUCOSE MONITORING SYSTEM MODELS, BGMS 71030-01 STRIPS: 7103-01 (20 COUNT)
NBW
System, Test, Blood Glucose, Over The Counter
138d
Cleared
Nov 19, 2008
AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET, MODEL K707M-5
JJY
Multi-analyte Controls, All Kinds (assayed)
63d
Cleared
Nov 17, 2008
EASYRA AMYLASE, BUN, GLU-H, TRIG, URIC REAGENT
JFJ
Catalytic Methods, Amylase
238d
Cleared
Nov 17, 2008
CHOLESTEROL OXIDASE JASE, AND GLYCEROL INASE TRIGLYCERIDES, MODEL NA
CHH
Enzymatic Esterase--oxidase, Cholesterol
257d
Cleared
Nov 12, 2008
DIAZYME LIQUID STABLE ENZYMATIC SODIUM ASSAY, MODEL DZ114B
MZU
System, Test, Sodium, Enzymatic Method
51d
Cleared
Nov 04, 2008
ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE MICROPLATE REAGENT KIT
NAK
System, Test, Biotinidase
274d
Cleared
Oct 31, 2008
IMDX ANALYZER, IMDXPREP REAGENT PLATE, IMDXPREP CALIBRATION PLATE, IMDXPREP CONTROL
DKZ
Enzyme Immunoassay, Amphetamine
296d
Cleared
Oct 23, 2008
VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 5600 INTEGRATED SYSTEM
JLW
Radioimmunoassay, Thyroid-stimulating Hormone
143d
Cleared
Oct 22, 2008
ONETOUCH VITA BLOOD GLUCOSE MONITORING SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
50d
Cleared
Oct 17, 2008
CARESENS BLOOD GLUCOSE MONITORING SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
198d
Cleared
Oct 17, 2008
ABX PENTRA HBA1C WB, CALIBRATOR, CONTROL AND HEMOLYSIS REAGENT
LCP
Assay, Glycosylated Hemoglobin
329d
Cleared
Oct 10, 2008
LOCI N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE CALIBRATOR, MODEL RC623
JIT
Calibrator, Secondary
25d
Cleared
Oct 08, 2008
GLUCOFACTS EXPRESS DIABETES MANAGEMENT SOFTWARE
NBW
System, Test, Blood Glucose, Over The Counter
41d
Cleared
Oct 07, 2008
ULTRA TRAK PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-455
NBW
System, Test, Blood Glucose, Over The Counter
28d
Cleared
Oct 06, 2008
RNA MEDICAL GLUCOSE AND B-KETONE CALIBRATION VERIFICATION CONTROLS
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
132d
Cleared
Sep 22, 2008
DIMENSION EXL N-TERNMIAL PRO-BRAIN NATRIURETIC PEPTIDE (NTP) FLEX REAGENT CARTRIDGE, MODEL RF623
NBC
Test, Natriuretic Peptide
11d
Cleared
Sep 18, 2008
GLUCOSE METER-CHECK CONTROL SOLUTION FOR BAYER ASCENSIA BLOOD GLUCOSE METER, MODEL: MC002
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
30d
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