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
11215 Chemistry devices
Cleared
Jan 03, 2003
WIENER LAB. CK-MB DS UV UNITEST, MODEL 28 X 2.5 ML CAT. NR. 1271354
JHW
U.v. Method, Cpk Isoenzymes
57d
Cleared
Dec 26, 2002
MODIFICATION TO ALKP
CJE
Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
42d
Cleared
Dec 24, 2002
RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA ANAYLZER
LBR
Ldl & Vldl Precipitation, Hdl
42d
Cleared
Dec 23, 2002
AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS)
CIJ
Saccharogenic, Amylase
75d
Cleared
Dec 23, 2002
HEMOSIL C-REACTIVE PROTEIN - HIGH SENSITIVITY AND HIGH SENSITIVITY CONTROLS
DCK
C-reactive Protein, Antigen, Antiserum, And Control
83d
Cleared
Dec 20, 2002
STAT PROFILE PHOX PLUS L ANALYZER
CHL
Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph
58d
Cleared
Dec 20, 2002
ACCESS TOTAL BHCG
JHI
Visual, Pregnancy Hcg, Prescription Use
64d
Cleared
Dec 19, 2002
COBAS INTEGRA CREATININE PLUS VER.2 ASSAY
JFY
Enzymatic Method, Creatinine
7d
Cleared
Dec 19, 2002
MAS CARDIOIMMUNE TL LOW LEVEL LIQUID ASSAYED CARDIAC MARKER CONTROL, DADE CARDIAC TL LOW LEVEL LIQUID ASSAYED CARDIAC MA
JJY
Multi-analyte Controls, All Kinds (assayed)
49d
Cleared
Dec 17, 2002
MAS T-MARKER, LEVEL 1,2 AND 3, DADE SPECIAL-T MARKER, LEVEL 1,2 AND 3
JJY
Multi-analyte Controls, All Kinds (assayed)
27d
Cleared
Dec 17, 2002
ST AIA-PACK TESTOSTERONE ASSAY
CDZ
Radioimmunoassay, Testosterones And Dihydrotestosterone
91d
Cleared
Dec 16, 2002
ABBOTT ARCHITECT FOLATE
CGN
Acid, Folic, Radioimmunoassay
68d
Cleared
Dec 16, 2002
SAS BLOOD/SERUM/URINE/URINE HCG
JHI
Visual, Pregnancy Hcg, Prescription Use
126d
Cleared
Dec 13, 2002
SURESTEP HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
25d
Cleared
Dec 11, 2002
MAS UA CONTROL LIQUID ASSAYED URINALYSIS CONTROL, DADE ASSAYED URINALYSIS CONTROL
JJW
Urinalysis Controls (assayed And Unassayed)
16d
Cleared
Dec 11, 2002
BILIRUBIN-SL (TOTAL) ASSAY, MODEL 284-10/30
CIG
Diazo Colorimetry, Bilirubin
68d
Cleared
Dec 10, 2002
VITROS CHEMISTRY PRODUCTS ALB SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 4
CIX
Bromcresol Green Dye-binding, Albumin
19d
Cleared
Dec 09, 2002
WIENER LAB GOT (AST) UV AA LIQUIDA
CIT
Nadh Oxidation/nad Reduction, Ast/sgot
48d
Cleared
Dec 09, 2002
WIENER LAB URICOSTAT ENZIMATICO AA LIQUIDA
KNK
Acid, Uric, Uricase (colorimetric)
48d
Cleared
Dec 09, 2002
WIENER LAB AMILASA 405 AA LIQUIDA
JFJ
Catalytic Methods, Amylase
48d
Cleared
Dec 09, 2002
ACCESS TOTAL T4 ASSAY
KLI
Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine
62d
Cleared
Dec 09, 2002
IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL
JKR
Radioimmunoassay, Calcitonin
67d
Cleared
Dec 06, 2002
LINICAL RF-CRP CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON CX SYSTEMS
JJY
Multi-analyte Controls, All Kinds (assayed)
36d
Cleared
Dec 06, 2002
BECTON DICKINSON DIABETES SOFTWARE
NBW
System, Test, Blood Glucose, Over The Counter
71d
Cleared
Nov 29, 2002
INSTANT-VIEW PROPOXYPHENE (PPX) URINE TEST
JXN
Enzyme Immunoassay, Propoxyphene
87d
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