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
11211 Chemistry devices
Cleared
Jan 02, 2004
NOVA GLUCOSE CONTROL SOLUTIONS
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
66d
Cleared
Dec 24, 2003
STRATUS CS ACUTE CARE TROPONIN I TESTPAK, MODEL CCTNI
MMI
Immunoassay Method, Troponin Subunit
50d
Cleared
Dec 23, 2003
TRIAGE BNP TEST FOR THE BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL CATALOG #98200
NBC
Test, Natriuretic Peptide
61d
Cleared
Dec 23, 2003
CLINITEST HCG PREGNANCY TEST
JHI
Visual, Pregnancy Hcg, Prescription Use
125d
Cleared
Dec 23, 2003
RANDOX EVIDENCE
DIO
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
323d
Cleared
Dec 19, 2003
INSTRINSIC FACTOR AB, CALIBRATORS, AND QC ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 387992, 387993, 387999
LIG
Radioassay, Intrinsic Factor Blocking Antibody
32d
Cleared
Dec 19, 2003
BAYER SPECIAL CHEMISTRY CONTROLS
JJY
Multi-analyte Controls, All Kinds (assayed)
58d
Cleared
Dec 19, 2003
QUANTEX CRP HIGH SENSITIVITY STANDARD MULTIPOINT, QUANTEX CRP HIGH SENSITIVITY CONTROLS VE CONTROLS 1/2
DCK
C-reactive Protein, Antigen, Antiserum, And Control
113d
Cleared
Dec 19, 2003
BAYER CLINITEK STATUS ANALYZER
KQO
Automated Urinalysis System
178d
Cleared
Dec 19, 2003
FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM, MODELS 11001, 16000, AND 16005
NBW
System, Test, Blood Glucose, Over The Counter
242d
Cleared
Dec 17, 2003
LIGHTCYCLER INSTRUMENT VERSION 1.2
JJF
Analyzer, Chemistry, Micro, For Clinical Use
19d
Cleared
Dec 17, 2003
BAYER RAPIDLAB 1200 SYSTEM
CHL
Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph
212d
Cleared
Dec 16, 2003
BAYER SPECIAL CHEMISTRY CALIBRATORS
JIX
Calibrator, Multi-analyte Mixture
55d
Cleared
Dec 15, 2003
PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRATORS
DKB
Calibrators, Drug Mixture
62d
Cleared
Dec 12, 2003
IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER
DHA
System, Test, Human Chorionic Gonadotropin
67d
Cleared
Dec 12, 2003
MISSION CONTROLS
JJS
Controls For Blood-gases, (assayed And Unassayed)
74d
Cleared
Dec 05, 2003
HDL-CHOLESTEROL PLUS 2ND GENERATION
LBS
Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl
18d
Cleared
Dec 04, 2003
RANDOX RX DAYTONA
CGA
Glucose Oxidase, Glucose
365d
Cleared
Dec 02, 2003
QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945
JJY
Multi-analyte Controls, All Kinds (assayed)
40d
Cleared
Nov 24, 2003
ROCHE DIAGNOSTICS URISYS 1100 URINE ANALYZER
KHE
Reagent, Occult Blood
12d
Cleared
Nov 21, 2003
ACON QUIK-CHECK II HOME PREGNANCY TEST STRIP
LCX
Kit, Test, Pregnancy, Hcg, Over The Counter
53d
Cleared
Nov 21, 2003
OLYMPUS LYOPHILIZED CALIBRATOR, MODELS DR0070 AND DR0071
JIX
Calibrator, Multi-analyte Mixture
85d
Cleared
Nov 20, 2003
MODIFICATION TO CALIBRATOR FOR AUTOMATIC SYSTEMS (CFAS)
JIX
Calibrator, Multi-analyte Mixture
15d
Cleared
Nov 14, 2003
BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEM
KXT
Enzyme Immunoassay, Digoxin
49d
Cleared
Nov 14, 2003
OLYMPUS HBA1C REAGENT, (CATALOG NUMBER OSR6192), OLYMPUS HBA1C CALIBRATOR, (CATOLOG NUMBER ODC3032)
LCP
Assay, Glycosylated Hemoglobin
197d
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