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
6145–6168 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Aug 12, 1992
DU PONT ACA PLUS IMMUNOASSSAY SYSTEM HCG CALIBRATO
K922696 · JIS
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 69d
Cleared Aug 12, 1992
LIPID CONTROLS
K922995 · JJX
Creative Laboratory Products, Inc.
Chemistry · 51d
Cleared Aug 12, 1992
NOVA TOTAL PROTEIN MODULE
K923266 · CEK
Nova Biomedical Corp.
Chemistry · 41d
Cleared Aug 11, 1992
WELLPREP 2000 SAMPLE PROCESSOR
K922183 · JQW
Denley Instruments, Inc.
Chemistry · 92d
Cleared Aug 10, 1992
DU PONT ACA PLUS IMMUNOASSAY SYSTEM HCG METHOD
K922697 · JHI
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 67d
Cleared Aug 10, 1992
AMERLITE FREE THYROID CONTROL SERA LAN.4002
K923165 · JJY
Eastman Kodak Company
Chemistry · 42d
Cleared Aug 05, 1992
ACCESS THEOPHYLLINE IMMUNOASSAY REAGENTS
K922823 · CGN
Bio-Rad Laboratories, Inc.
Chemistry · 55d
Cleared Aug 04, 1992
REFLAB SYSTEM PACK LIQUID FRUCTOSAMINE REAGENT
K920397 · LCP
Medical Analysis Systems, Inc.
Chemistry · 187d
Cleared Aug 04, 1992
CALCIUM (AZ III) REAGENT
K922835 · CJY
King Diagnostics, Inc.
Chemistry · 53d
Cleared Aug 03, 1992
BIOTROL BICARBONATE STANDARDS
K921855 · JIS
Biotrol, USA, Inc.
Chemistry · 108d
Cleared Jul 30, 1992
MODEL 654 ANALYZER
K921403 · JIH
Ciba Corning Diagnostics Corp.
Chemistry · 128d
Cleared Jul 30, 1992
HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNO
K921745 · JFH
Hybritech, Inc.
Chemistry · 108d
Cleared Jul 30, 1992
ENZIP URINARY MICROALBUMIN TEST
K922032 · JIR
Diagnostic Specialties
Chemistry · 90d
Cleared Jul 30, 1992
RAI-TROL FRUCTOSAMINE SERUM CONTROLS I AND II
K922904 · JJX
Reagents Applications, Inc.
Chemistry · 44d
Cleared Jul 30, 1992
AFFIRM PROCESSOR
K923268 · JQW
Microprobe Corp.
Chemistry · 24d
Cleared Jul 28, 1992
COBAS CORE IMMUNOCHEMISTRY SYSTEM
K921180 · JJQ
Roche Diagnostic Systems, Inc.
Chemistry · 140d
Cleared Jul 28, 1992
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM
K921302 · JHI
Vitek Systems, Inc.
Chemistry · 131d
Cleared Jul 28, 1992
OLYMPUS ALANINE AMINOTRANSFERASE REAGENT
K922884 · CKA
Olympus Corp.
Chemistry · 42d
Cleared Jul 28, 1992
OLYMPUS ASPARTATE AMINOTRANSFERASE REAGENT
K922885 · CIT
Olympus Corp.
Chemistry · 42d
Cleared Jul 27, 1992
NOVA NUCLEUS CLINICAL CHEMICAL SYST, MODIFICATION
K921937 · JGS
Nova Biomedical Corp.
Chemistry · 94d
Cleared Jul 23, 1992
IL TEST BILIRUBIN TOTAL/DIRECT
K920653 · CIG
Instrumentation Laboratory CO
Chemistry · 162d
Cleared Jul 23, 1992
REP SPE PLUS (ACID BLUE) SYSTEM,# 3173/3174/3175
K922024 · CEF
Helena Laboratories
Chemistry · 83d
Cleared Jul 21, 1992
WAKO AUTOKIT LIPASE-COLOR
K921249 · CHI
Wako Chemicals USA, Inc.
Chemistry · 127d
Cleared Jul 21, 1992
DIA STRIPS SYSTEM, MODIFIED
K921495 · JIO
Symcon Intl., Inc.
Chemistry · 137d