FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,237 results
8473–8496 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Mar 16, 1987
IQ FTI IMMUNOASSAY
K865104 · CEC
Bd Becton Dickinson Vacutainer...
Chemistry · 76d
Cleared Mar 13, 1987
SHBG IRMA KIT
K861679 · CDZ
Farmos Group , Ltd.
Chemistry · 316d
Cleared Mar 13, 1987
SYVA ETS SYSTEM
K863245 · JJF
Syva Co.
Chemistry · 203d
Cleared Mar 13, 1987
UBIMAGIWEL(TM)HCG QUANTITATIVE AND QUALITATIVE
K864174 · JHI
United Biotech, Inc.
Chemistry · 140d
Cleared Mar 13, 1987
CO2 REAGENT SET
K864313 · CIE
Hf Scientific, Inc.
Chemistry · 130d
Cleared Mar 13, 1987
TDXR CANNABINOIDS
K864751 · LDJ
Abbott Laboratories
Chemistry · 98d
Cleared Mar 13, 1987
MEDICA EASYLYTE SODIUM/POTASSIUM ANALYZER
K864872 · JGS
Medica Corp.
Chemistry · 91d
Cleared Mar 13, 1987
THYROID STIMULATING HORMONE (TSH IRMA) RIA KIT
K865071 · JLW
Immuchem Corp.
Chemistry · 74d
Cleared Mar 13, 1987
AMRESCO FLOW PAC CARBON DIOXIDE (CO2) REAGENTS
K870025 · KMS
American Research Products Co.
Chemistry · 67d
Cleared Mar 13, 1987
COAT-A-COUNT IRMA HCG KIT AND ITS COMPONENTS
K870106 · JHI
Diagnostic Products Corp.
Chemistry · 60d
Cleared Mar 13, 1987
FAST GLUCOSE
K870631 · CGA
Sclavo, Inc.
Chemistry · 28d
Cleared Mar 13, 1987
FAST URIC ACID
K870632 · KNK
Sclavo, Inc.
Chemistry · 28d
Cleared Mar 13, 1987
RAICHEM(TM) PHOSPHORUS REAGENT, RAPID ENDPOINT
K870776 · CEO
Reagents Applications, Inc.
Chemistry · 15d
Cleared Mar 13, 1987
PROGRESS PLUS SELECTIVE CHEMISTRY ANALYZER
K870777 · JJF
Kone Instruments, Inc.
Chemistry · 15d
Cleared Mar 13, 1987
INTERSECT SYSTEMS TRIGLYCERIDE-GPO REAGENT
K870827 · CDT
Intersect Systems, Inc.
Chemistry · 10d
Cleared Mar 13, 1987
INTERSECT SYSTEMS ENZYMATIC CHOLESTEROL REAGENT
K870828 · CHH
Intersect Systems, Inc.
Chemistry · 10d
Cleared Mar 12, 1987
BECKMAN EPSILON(TM) LIPASE TEST KIT
K864438 · CET
Beckman Instruments, Inc.
Chemistry · 120d
Cleared Mar 12, 1987
IQ FREE T4 IMMUNOASSAY
K864658 · CEC
Bd Becton Dickinson Vacutainer...
Chemistry · 104d
Cleared Mar 12, 1987
AFFINITY(TM) HTSH IMMUNIT(TM)
K865081 · JLW
Bd Becton Dickinson Vacutainer...
Chemistry · 72d
Cleared Mar 12, 1987
AFFINITY(TM) SYSTEM
K865105 · JJE
Bd Becton Dickinson Vacutainer...
Chemistry · 72d
Cleared Mar 10, 1987
DIMENSION-WBG
K863223 · CGA
Dimension Diagnostics
Chemistry · 201d
Cleared Mar 10, 1987
TANDEMR ICONR II HCG(SERUM) IMMUNOENZYMETRIC ASSAY
K865057 · JHI
Hybritech, Inc.
Chemistry · 76d
Cleared Mar 10, 1987
VIS-CUBE HCG (EIA) LYOPHILIZED JPL-044
K870259 · JHI
Leeco Diagnostics, Inc.
Chemistry · 46d
Cleared Mar 10, 1987
EASY-TEST CREATINE KINASE-MB (CK-MB) #16615
K870462 · CGS
Em Diagnostic Systems, Inc.
Chemistry · 35d