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
181d
Avg (2y)
1976
Since
11216 Chemistry devices
Cleared
Jan 17, 2002
RANDOX THEOPHYLLINE
KLS
Enzyme Immunoassay, Theophylline
225d
Cleared
Jan 15, 2002
SYNCHRON SYSTEMS PANCREATIC AMYLASE (PAM) REAGENT
JFJ
Catalytic Methods, Amylase
43d
Cleared
Jan 15, 2002
STAT PROFILE PHOX BASIC ANALYZER
CHL
Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph
67d
Cleared
Dec 21, 2001
BIOSCANNER PLUS
NBW
System, Test, Blood Glucose, Over The Counter
8d
Cleared
Dec 21, 2001
MODIFICATION TO MAS CARDIOLMMUNE TL
JJY
Multi-analyte Controls, All Kinds (assayed)
17d
Cleared
Dec 21, 2001
STANDARD A, STANDARD B, STANDARD C, CAL, SLOPE
JIT
Calibrator, Secondary
31d
Cleared
Dec 21, 2001
AST (SGOT)
CIT
Nadh Oxidation/nad Reduction, Ast/sgot
44d
Cleared
Dec 21, 2001
WIENER LAB. CA-COLOR AA, MODEL 4 X 50 ML CAT.N 1152002
CIC
Cresolphthalein Complexone, Calcium
45d
Cleared
Dec 21, 2001
ACS 180 HOMOCYSTEINE ASSAY
LPS
Urinary Homocystine (nonquantitative) Test System
51d
Cleared
Dec 21, 2001
SPIFE 2000/3000 LIPOPROTEIN
JHO
Electrophoretic Separation, Lipoproteins
64d
Cleared
Dec 21, 2001
WIENER LAB. GLICEMIA ENZIMATICA AA MODELS 1 X 250 ML CAT. #1400106
CGA
Glucose Oxidase, Glucose
183d
Cleared
Dec 18, 2001
MODIFICATION TO SYNCHRON LX CLINICAL CHEMISTRY SYSTEMS (LX20 AND LX20 PRO)
JFL
Ph Rate Measurement, Carbon-dioxide
11d
Cleared
Dec 18, 2001
PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIES
CGZ
Electrode, Ion-specific, Chloride
61d
Cleared
Dec 18, 2001
ADVIA CENTAUR HOMOCYSTEINE ASSAY
LPS
Urinary Homocystine (nonquantitative) Test System
64d
Cleared
Dec 18, 2001
DC-UIBC-CO2-CAL, MODEL SE-153
JIX
Calibrator, Multi-analyte Mixture
85d
Cleared
Dec 14, 2001
AIA-PACK CTNI 2ND-GEN ASSAY
MMI
Immunoassay Method, Troponin Subunit
113d
Cleared
Dec 13, 2001
NICHOLS ADVANTAGE CHEMILUMINESCENCE BIO-INTACT PARATHYROID HORMONE (1-84) IMMUNOASSAY
CEW
Radioimmunoassay, Parathyroid Hormone
9d
Cleared
Dec 07, 2001
MAS LIPID CONTROL, LIQUID ASSAYED LIPID CONTROL, LEVEL 1 AND 2, DADE LIPID CONTROL, LIQUID ASSAYED LIPID CONTROL, LEVEL
JJY
Multi-analyte Controls, All Kinds (assayed)
24d
Cleared
Dec 06, 2001
BAYER ADVIA IMS SYSTEM
DCN
System, Test, C-reactive Protein
135d
Cleared
Dec 05, 2001
ACCU-CHEK ACTIVE TEST SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
135d
Cleared
Dec 05, 2001
MODIFICATION TO BLOOD GLUCOSE MONITORING SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
176d
Cleared
Nov 27, 2001
WIENER LAB. GOT (AST) UV AA. WEINER LAB. GOT (AST) UV UNITEST, MODELS 10 * 20 ML CAT. NR. 1751302 AND 20 * 2 ML CAT NR.
CIT
Nadh Oxidation/nad Reduction, Ast/sgot
68d
Cleared
Nov 20, 2001
IMMULITE INTACT PTH, IMMULITE 2000 INTACT PTH, MODELS LKPP1 (100 TESTS), LKPP5 (500 TESTS), L2KPP2 (200 TESTS), L2KPP6
CEW
Radioimmunoassay, Parathyroid Hormone
25d
Cleared
Nov 20, 2001
VALIDATE CHEM 7 CALIBRATION VERIFICATION TEST SET, MODEL 10007
JJY
Multi-analyte Controls, All Kinds (assayed)
50d
Cleared
Nov 20, 2001
BIOSCANNER 2000
CGA
Glucose Oxidase, Glucose
145d
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