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
5809–5832 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Aug 10, 1993
ULTRA+ BLOOD GLUCOSE MONITORING TEST STRIP
K922136 · CGA
Home Diagnostics, Inc.
Chemistry · 475d
Cleared Aug 10, 1993
DIASCAN BLOOD GLUCOSE MONITORING TEST STRIP
K922137 · CGA
Home Diagnostics, Inc.
Chemistry · 475d
Cleared Aug 09, 1993
DU PONT ACA NEV/EEV VERIFIER
K930501 · JIS
Dupont Medical Products
Chemistry · 189d
Cleared Aug 05, 1993
CENTRICON -50 CONCENTRATOR
K930168 · JJH
Amicon, Inc.
Chemistry · 204d
Cleared Aug 03, 1993
REP SPE HI-RES TEMPLATE SYSTEM, CAT 3276/3277/3278
K930317 · CEF
Helena Laboratories
Chemistry · 193d
Cleared Aug 03, 1993
BICARBONATE
K931887 · KHS
Em Diagnostic Systems, Inc.
Chemistry · 110d
Cleared Aug 03, 1993
MARKSMAN ARTERIAL BLOOD GAS SYRINGE
K931924 · JKA
Martech Medical Products, Inc.
Chemistry · 109d
Cleared Aug 03, 1993
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (PHOS)
K932729 · CEO
Eastman Kodak Company
Chemistry · 57d
Cleared Aug 03, 1993
DELFIA TESTTOSTERONE KIT
K932951 · CDZ
Wallac OY
Chemistry · 47d
Cleared Aug 02, 1993
DOCUMENT CHEM IV CALIBRATION VERIFICATION TEST SET
K932870 · JJX
Casco Standards
Chemistry · 49d
Cleared Aug 02, 1993
CIBA CORNING ACS PROGESTERONE IMMUNOASSAY
K932955 · JLS
Ciba Corning Diagnostics Corp.
Chemistry · 46d
Cleared Jul 28, 1993
TRIGLYCERIDES GPO-PAP
K923508 · CDT
Randox Laboratories, Ltd.
Chemistry · 378d
Cleared Jul 28, 1993
ACCUTEX BETA-HCG TEST
K926112 · JHJ
J.S. Medical Assoc.
Chemistry · 237d
Cleared Jul 28, 1993
CKMB ISOENZYME CONTROL(HUMAN) LEVEL 1,2,& 3
K932658 · JJX
More Diagnostics
Chemistry · 56d
Cleared Jul 28, 1993
MULTI LEVEL CONTROL FOR CKMB ISOENSYME IN SYRUM
K932659 · JJX
More Diagnostics
Chemistry · 56d
Cleared Jul 27, 1993
ADRENOCORTICOTROPIC/ACTH ANALYSIS PRODUCT
K926396 · CKG
Nichols Institute
Chemistry · 218d
Cleared Jul 27, 1993
DELFIA CORTISOL KIT
K930732 · JFT
Wallac OY
Chemistry · 166d
Cleared Jul 27, 1993
VIDAS CORTISOL (CORT) ASSAY & SERUM FREE DILUTENT
K931031 · JFT
Biomerieux Vitek, Inc.
Chemistry · 148d
Cleared Jul 27, 1993
CHEMILUMINESCENCE DHEA-S IMMUNOASSAY
K931601 · JKC
Nichols Institute
Chemistry · 117d
Cleared Jul 27, 1993
TOTAL BILIRUBIN
K931888 · CIG
Em Diagnostic Systems, Inc.
Chemistry · 103d
Cleared Jul 27, 1993
CREATINE KINASE TEST
K931889 · CGS
Em Diagnostic Systems, Inc.
Chemistry · 103d
Cleared Jul 27, 1993
DU PONT ISE SENSOR CARTRIDGE/REVISED TCO2 ELECTROD
K932044 · CEM
Dupont Medical Products
Chemistry · 91d
Cleared Jul 22, 1993
URIC ACID ENZYMATIC COLORIMERIC KIT
K923503 · KNK
Randox Laboratories, Ltd.
Chemistry · 372d
Cleared Jul 22, 1993
IQ TUPTAKE ASSAY
K931294 · KHQ
Becton Dickinson Advanced Diagnostics
Chemistry · 129d