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
Jan 16, 2009
EASYMAX N SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL: EPS08008
NBW
System, Test, Blood Glucose, Over The Counter
88d
Cleared
Jan 16, 2009
EASY2CHECK BLOOD GLUCOSE AND BLOOD PRESSURE MONITORING SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
136d
Cleared
Jan 16, 2009
CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2
JJW
Urinalysis Controls (assayed And Unassayed)
197d
Cleared
Jan 16, 2009
COBAS INTEGRA 400/800 BILIRUBIN TOTAL
CIG
Diazo Colorimetry, Bilirubin
263d
Cleared
Jan 13, 2009
DIAZYME LP(A) ASSAY
DFC
Lipoprotein, Low-density, Antigen, Antiserum, Control
138d
Cleared
Jan 09, 2009
FORA TD-4245 BLOOD GLUCOSE MONITORING SYSTEM, TD-4245
CGA
Glucose Oxidase, Glucose
30d
Cleared
Jan 09, 2009
AMNISURE FETAL MEMBRANES RUPTURE TEST, MODEL FMRT-1
NQM
Immunoassay For Detection Of Amniotic Fluid Protein(s).
203d
Cleared
Jan 08, 2009
ADVIA CHEMISTRY HEMOGLOBIN A1C, ADVIA CHEMISTRY A1C CALIBRATORS
LCP
Assay, Glycosylated Hemoglobin
189d
Cleared
Jan 08, 2009
MYGLUCOHEALTH GLUCOSE MONITORING SYSTEMS
NBW
System, Test, Blood Glucose, Over The Counter
205d
Cleared
Dec 24, 2008
ENVISION BLOOD GLUCOSE TEST SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
161d
Cleared
Dec 22, 2008
ABT GLUCOSE CONTROL SOLUTION
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
21d
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 16, 2008
TOTAL BILIRUBIN L3K, MODEL 295-10 AND 295-30
CIG
Diazo Colorimetry, Bilirubin
132d
Cleared
Dec 16, 2008
VACUETTE BLOOD COLLECTION TUBE WITH CLOT ACTIVATOR AND GEL SEPARATOR
JKA
Tubes, Vials, Systems, Serum Separators, Blood Collection
162d
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
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