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
8353–8376 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jun 11, 1987
ALLELIX PREGNANCY DETECTION KIT 48 TEST KIT
K871308 · JHI
Allelix, Inc.
Chemistry · 71d
Cleared Jun 11, 1987
MICROCHECK LH OVULATION TEST
K871602 · CEP
Syntron Bioresearch, Inc.
Chemistry · 48d
Cleared Jun 11, 1987
TDXR REA(TM) ETHANOL
K871645 · DIC
Abbott Laboratories
Chemistry · 44d
Cleared Jun 11, 1987
IL MONARCH 1000 CLINICAL CHEMISTRY ANALYTICAL SYS.
K871973 · JJG
Instrumentation Laboratory CO
Chemistry · 20d
Cleared Jun 11, 1987
GAMMA GLUTAMYLTRANSFERASE REAGENT
K871979 · JPZ
Intersect Systems, Inc.
Chemistry · 20d
Cleared Jun 11, 1987
MULTICHEM LDH-L REAGENT
K872010 · CFJ
Simmler, Inc.
Chemistry · 16d
Cleared Jun 08, 1987
DSL ESTRADIAL RADIOIMMUNOASSAY (DSL-4400)
K870405 · CHP
Diagnostic Systems Laboratories, Inc.
Chemistry · 125d
Cleared Jun 05, 1987
MULTICHEM TOTAL PROTEIN REAGENT #S0928
K871975 · CEK
Simmler, Inc.
Chemistry · 14d
Cleared Jun 05, 1987
MULTICHEM GLUCOSE HEXOKINASE REAGENT #S0919
K871976 · CFR
Simmler, Inc.
Chemistry · 14d
Cleared Jun 04, 1987
ULTRAVIOLET ASPARTATE AMINO-TRANS (UV-AST/UV-GOT)
K871780 · CIT
Biochemical Trade, Inc.
Chemistry · 29d
Cleared Jun 03, 1987
BILIRUBIN TESTER
K870095 · CIG
Wako Chemicals USA, Inc.
Chemistry · 145d
Cleared Jun 03, 1987
TANDEM(R) ICON(R) QSR(TM) HCG IMMUNO. ASSAY KIT
K871235 · JHI
Hybritech, Inc.
Chemistry · 68d
Cleared Jun 03, 1987
ANALYZER: NOVA STAT PROFILE 3 ANALYZER
K871397 · CHL
Nova Biomedical Corp.
Chemistry · 57d
Cleared Jun 03, 1987
ULTRAVIOLET LACTATE DEHYDROGENASE REAGENT SET
K871781 · CFJ
Biochemical Trade, Inc.
Chemistry · 28d
Cleared Jun 03, 1987
THE URIC ACID REAGENT SET
K871902 · KNK
Macomb Biotechnology, Inc.
Chemistry · 19d
Cleared Jun 03, 1987
D.A.T. (TM) AMYLASE REAGENT
K871943 · CIJ
Behring Diagnostics, Inc.
Chemistry · 15d
Cleared Jun 01, 1987
STANBIO ALPHA-AMYLASE TEST SET, CATALOG 0180-715
K870746 · JFJ
Stanbio Laboratory
Chemistry · 96d
Cleared Jun 01, 1987
ALKALINE PHOSPHATASE INDOLYL BLUE REAGENT
K870890 · CIN
Helena Laboratories
Chemistry · 88d
Cleared May 28, 1987
AFFINITY (TM) HCG IMMUNIT (TM)
K870627 · JHI
Bd Becton Dickinson Vacutainer...
Chemistry · 104d
Cleared May 28, 1987
CIBA CORNING MODEL 664/FAST 4 SYSTEM
K871028 · JGS
Ciba Corning Diagnostics Corp.
Chemistry · 73d
Cleared May 28, 1987
FLAME PHOTOMETER STANDARD #60081 120 NA/2K
K871182 · JIX
In Vitro Diagnostics, Inc.
Chemistry · 65d
Cleared May 28, 1987
FLAME PHOTOMETER STANDARD #60082 140 NA/5K
K871183 · JIX
In Vitro Diagnostics, Inc.
Chemistry · 65d
Cleared May 28, 1987
FLAME PHOTOMETER STANDARD #60083 160 NA/8K
K871184 · JIX
In Vitro Diagnostics, Inc.
Chemistry · 65d
Cleared May 28, 1987
LITHIUM INTERNAL STANDARD 1 MEQ/L #60085
K871185 · JIS
In Vitro Diagnostics, Inc.
Chemistry · 65d