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
11219 Chemistry devices
Cleared
Mar 01, 2001
ELECSYS TESTOSTERONE CALSET II
JIT
Calibrator, Secondary
119d
Cleared
Feb 28, 2001
CARDIOIMMUNE TL CARDIAC MARKER CONTROL LEVELS 1, 2, 3, AND MULTI-PACK
JJY
Multi-analyte Controls, All Kinds (assayed)
47d
Cleared
Feb 21, 2001
PHOSPHORUS REAGENT
CEO
Phosphomolybdate (colorimetric), Inorganic Phosphorus
64d
Cleared
Feb 20, 2001
DIMENSION ENZYMATIC CARBONATE (ECO2) CALIBRATOR, CATALOG DC137
JIT
Calibrator, Secondary
28d
Cleared
Feb 20, 2001
TOTAL BILIRUBIN REAGENT
CIG
Diazo Colorimetry, Bilirubin
64d
Cleared
Feb 14, 2001
ELECSYS HCG+B CALCHECK
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
20d
Cleared
Feb 14, 2001
IMMULITE CK-MB, MODEL LKMB1 (100 TESTS), LKMB5 (500 TESTS)
JHX
Fluorometric Method, Cpk Or Isoenzymes
50d
Cleared
Feb 14, 2001
DELFIA NEONATAL IRT KIT, MODEL A005-110
CGZ
Electrode, Ion-specific, Chloride
78d
Cleared
Feb 12, 2001
TOTAL BILIRUBIN
CIG
Diazo Colorimetry, Bilirubin
63d
Cleared
Feb 12, 2001
AUTODELFIA NEONATAL IRT KIT, MODEL B005-112
CGZ
Electrode, Ion-specific, Chloride
76d
Cleared
Feb 05, 2001
ADVIA CENTAUR AND ACS: 180 FOLATE IMMUNOASSAY
CGN
Acid, Folic, Radioimmunoassay
31d
Cleared
Feb 05, 2001
RANDOX TRANSFERRIN
DDG
Transferrin, Antigen, Antiserum, Control
168d
Cleared
Feb 02, 2001
EASYELECTROLYTE NA/K/LI ANALYZER & RAPIDLYTE NA/K/LI ANALYZER
JGS
Electrode, Ion Specific, Sodium
179d
Cleared
Jan 29, 2001
DIRECT BILIRUBIN
CIG
Diazo Colorimetry, Bilirubin
60d
Cleared
Jan 26, 2001
ELECSYS FSH CALSET II
JIT
Calibrator, Secondary
85d
Cleared
Jan 25, 2001
ELECSYS HCG STAT CLASET II
JIS
Calibrator, Primary
35d
Cleared
Jan 25, 2001
STRATUS CS STAT FLUOROMETRIC ANALYZER BHCG TESTPAK,TEST SYSTEM, MODEL CBHCG, BHCG CALPAK,MODEL CBHCG-C, BHCG DILPAK, MOD
DHA
System, Test, Human Chorionic Gonadotropin
56d
Cleared
Jan 22, 2001
WAKO CRP-UL, CRP-UL CALIBRATOR SET
DCN
System, Test, C-reactive Protein
89d
Cleared
Jan 22, 2001
EMIT 2000 TOBRAMYCIN ASSAY EMIT 2000 TOBRAMYCIN CALIBRATORS
KLB
Radioimmunoassay, Tobramycin
89d
Cleared
Jan 22, 2001
GLUCOSMART BLOOD GLUCOSE MONITORING SYSTEM
CGA
Glucose Oxidase, Glucose
152d
Cleared
Jan 22, 2001
GLUCOSURE BLOOD GLUCOSE MONITORING SYSTEM
CGA
Glucose Oxidase, Glucose
152d
Cleared
Jan 17, 2001
LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901
NDW
Assay, Porphyrin, Spectrophotometry, Lithium
58d
Cleared
Jan 17, 2001
ELECSYS DHEA-S
JKC
Radioimmunoassay, Dehydroepiandrosterone (free And Sulfate)
99d
Cleared
Dec 22, 2000
SYNCHRON SYSTEMS AMMONIA REAGENT
JIF
Enzymatic Method, Ammonia
71d
Cleared
Dec 20, 2000
ELECSYS DHEA-S CALCHECK
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
14d
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