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
6025–6048 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Nov 16, 1992
AST (GOT) - ASPARTATE AMINOTRANSFERASE
K923505 · CIT
Randox Laboratories, Ltd.
Chemistry · 124d
Cleared Nov 16, 1992
ALT (GPT) - ALANINE AMINOTRANSFERASE
K923510 · CKA
Randox Laboratories, Ltd.
Chemistry · 124d
Cleared Nov 16, 1992
VISTA FREE THYROXINE ASSAY
K923572 · CEC
Syva Co.
Chemistry · 122d
Cleared Nov 16, 1992
AIA-PACK PAP CALIBRATION VERIFICATION TEST SET
K924854 · JJX
Tosoh Medics, Inc.
Chemistry · 49d
Cleared Nov 16, 1992
AIA-PACK T-U CALIBRATION VERIFICATION TEST SET
K924855 · JJX
Tosoh Medics, Inc.
Chemistry · 49d
Cleared Nov 16, 1992
AIA-PACK FSH CALIBRATION VERIFICATION TEST SET
K924863 · JJX
Tosoh Medics, Inc.
Chemistry · 49d
Cleared Nov 16, 1992
OLYMPUS LACTATE DEHYDROGENASE REAGENT
K924965 · CFJ
Olympus Corp.
Chemistry · 47d
Cleared Nov 10, 1992
STATPAL II BLOOD GAS ANALYSIS SYSTEM
K922631 · CHL
Ppg Industries, Inc.
Chemistry · 160d
Cleared Nov 09, 1992
SYNERMED HDL CHOLESTLEROL REAGENT KIT
K924427 · LBR
Synermed, Inc.
Chemistry · 69d
Cleared Nov 09, 1992
EMDS ALKALINE PHOSPHATASE (ALP) TEST
K924574 · CJE
Em Diagnostic Systems, Inc.
Chemistry · 60d
Cleared Nov 06, 1992
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (NAIL)
K924471 · JGS
Eastman Kodak Company
Chemistry · 65d
Cleared Nov 06, 1992
SYSTEMATE PLUS TRIGLYCERIDE-GLYCEROL BLANKED TEST
K924573 · CDT
Em Diagnostic Systems, Inc.
Chemistry · 57d
Cleared Nov 06, 1992
NOVA 12 ANALYZER, MODIFICATION
K924743 · CGA
Nova Biomedical Corp.
Chemistry · 53d
Cleared Nov 06, 1992
NOVA 13 ANALYZER, MODIFICATION
K924864 · CGZ
Nova Biomedical Corp.
Chemistry · 56d
Cleared Nov 05, 1992
WELLWASH 4 MARK II
K922803 · JQW
Denley Instruments, Inc.
Chemistry · 148d
Cleared Nov 05, 1992
DOCUMENT CHEM III CALIBRATION VERIFICATION TEST
K923793 · JJX
Casco Standards
Chemistry · 100d
Cleared Nov 05, 1992
DOCUMENT CHEM II CALIBRATION VERIFICATION TEST SET
K923794 · JJX
Casco Standards
Chemistry · 100d
Cleared Nov 05, 1992
DOCUMENT CHEM I CALIBRATION VERIFICATION TEST SET
K923795 · JJY
Casco Standards
Chemistry · 100d
Cleared Nov 05, 1992
DOCUMENT CHEM V CALIBRATION VERIFICATION TEST SET
K923821 · JJX
Casco Standards
Chemistry · 98d
Cleared Nov 02, 1992
I-STAT(TM) LEVELS 1,2,3 CONTROLS
K921477 · JJY
I-Stat Corp.
Chemistry · 217d
Cleared Nov 02, 1992
KING DIAGNOSTICS GLUCOSE (HK) REAGENT
K923129 · CFR
King Diagnostics, Inc.
Chemistry · 129d
Cleared Oct 28, 1992
LIPASE HYDROLYSIS/GLYCEROT KINASE ENZYME, TRIGLYC
K924694 · CDT
Olympus Corp.
Chemistry · 42d
Cleared Oct 26, 1992
KODAK AMERLITE MAB FT3 ASSAY
K922713 · CEC
Eastman Kodak Company
Chemistry · 143d
Cleared Oct 26, 1992
IL TEST AST, PN 35312
K923641 · CIT
Instrumentation Laboratory CO
Chemistry · 97d