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
8641–8664 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Nov 24, 1986
UREA NITROGEN(BUN)
K863925 · CDQ
Tech-Co, Inc.
Chemistry · 47d
Cleared Nov 24, 1986
CHOLESTEROL
K863927 · CHH
Tech-Co, Inc.
Chemistry · 47d
Cleared Nov 24, 1986
LUTEINIZING HORMONE (LH-IRMA) RIA KIT
K864144 · CEP
Immuchem Corp.
Chemistry · 33d
Cleared Nov 24, 1986
PROGESTERONE SYSTEM BY EIA
K864156 · JLS
Intl. Bioclinical, Inc.
Chemistry · 32d
Cleared Nov 24, 1986
VISION (TM) GGTP
K864208 · JPZ
Abbott Laboratories
Chemistry · 28d
Cleared Nov 21, 1986
TANDEM-M IMMUNOENZYMETRIC ASSAY FOR THYR/STIM/HORM
K863859 · JLW
Hybritech, Inc.
Chemistry · 49d
Cleared Nov 21, 1986
TANDEM-M IMMUNOENZYMETRIC ASSAY FOR PROLACTIN
K863860 · CFT
Hybritech, Inc.
Chemistry · 49d
Cleared Nov 21, 1986
TANDEM-M IMMUNOENZYMETRIC ASSAY FOR HUM/CHOR/GONA
K863861 · JHI
Hybritech, Inc.
Chemistry · 49d
Cleared Nov 13, 1986
VISION (TM) CALCIUM
K863670 · CIC
Abbott Laboratories
Chemistry · 56d
Cleared Nov 13, 1986
AMYLASE,CALCIUM,CHLORIDE & TRIGLYCERIDES ON CHEM 1
K863719 · CIJ
Technicon Instruments Corp.
Chemistry · 51d
Cleared Nov 13, 1986
IMMUNO-CEPT D (BETA-MONOCLONAL)
K863741 · JHJ
Immunostics Co., Inc.
Chemistry · 51d
Cleared Nov 13, 1986
LIPASE HYDROLYSIS/GLYCEROL KINASE, TRIGLYCERIDES
K863874 · CDT
Electro-Nucleonics Laboratories, Inc.
Chemistry · 41d
Cleared Nov 13, 1986
GLUCOSE OXIDASE
K863926 · CGA
Tech-Co, Inc.
Chemistry · 36d
Cleared Nov 13, 1986
TERUMO SENSIBEAD(TM) EIA HLH KIT
K863929 · CEP
Terumo Medical Corp.
Chemistry · 36d
Cleared Nov 13, 1986
A-GENT(TM) LIQUID GLUCOSE TRINDER
K863948 · CGA
Abbott Laboratories
Chemistry · 34d
Cleared Nov 13, 1986
UBI MAGIWEL(TM) FSH QUANTITATIVE
K864080 · CGJ
United Biotech, Inc.
Chemistry · 24d
Cleared Nov 05, 1986
MONO ACU-SLIDE TEST
K861211 · JHJ
Cal-Tech Diagnostics, Inc.
Chemistry · 219d
Cleared Nov 05, 1986
UNIDEX GLUCOSE TEST STRIP
K862984 · CGA
Unidex, Inc.
Chemistry · 90d
Cleared Nov 05, 1986
THEOFAST(TM) TEST PACKAGE
K863475 · LER
3M Company
Chemistry · 57d
Cleared Nov 05, 1986
LYTENING 2
K863521 · JGS
Amdev, Inc.
Chemistry · 56d
Cleared Nov 05, 1986
EMDS(TM) CREATININE(CREA) TESTPACKS, #67669/95
K863738 · CGX
Em Diagnostic Systems, Inc.
Chemistry · 43d
Cleared Nov 05, 1986
HCG CONTROL KIT
K863744 · JJX
Monoclonal Antibodies, Inc.
Chemistry · 42d
Cleared Nov 05, 1986
VMAX KINETIC MICROPLATE READER
K863802 · JJQ
Molecular Devices Corp.
Chemistry · 37d
Cleared Nov 05, 1986
METH. & CALI. FOR THE DIMENSION CLINI/CHEM. SYSTEM
K863840 · JJE
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 35d