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.

176,325 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,249 results
12025–12048 of 13,249
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Feb 13, 1980
DURAZYME GPT/ALT
K800115 · CKA
American Monitor Corp.
Chemistry · 26d
Cleared Feb 13, 1980
DURAZYME GOT/AST
K800116 · CIT
American Monitor Corp.
Chemistry · 26d
Cleared Feb 13, 1980
LDH (L-P) REAGENT
K800120 · CFJ
Gilford Diagnostics
Chemistry · 26d
Cleared Feb 13, 1980
RSL (125 L) PROGESTERONE KIT
K800126 · JLS
Radioassay Systems Laboratories, Inc.
Chemistry · 26d
Cleared Feb 13, 1980
CENTRIFICHEM CK
K800127 · CGS
Union Carbide Corp.
Chemistry · 26d
Cleared Feb 13, 1980
CENTRIFICHEM BUN
K800128 · CDQ
Union Carbide Corp.
Chemistry · 26d
Cleared Feb 13, 1980
CENTRIFICHEM CREATININE
K800129 · CEX
Union Carbide Corp.
Chemistry · 26d
Cleared Feb 13, 1980
CENTRIFICHEM URIC ACID
K800130 · CDO
Union Carbide Corp.
Chemistry · 26d
Cleared Feb 13, 1980
ACCUSTROKE PIPET
K800141 · JQW
Beckman Instruments, Inc.
Chemistry · 23d
Cleared Feb 13, 1980
VENTRE/SEP T3 UPTAKE RADIOASSAY
K800165 · KHQ
Ventrex Laboratories, Inc.
Chemistry · 19d
Cleared Feb 13, 1980
AMES RIALYZE - CHROMATOGRAPHY TUBES
K800169 · CDX
Miles Laboratories, Inc.
Chemistry · 19d
Cleared Feb 13, 1980
AMES RIALYZE - UPTAKE CHROM. TUBES
K800170 · KHQ
Miles Laboratories, Inc.
Chemistry · 19d
Cleared Feb 13, 1980
EMC-M-175, THYROXINE - 100 TUBES
K800187 · CDX
Endocrine-Metabolic Center
Chemistry · 15d
Cleared Feb 13, 1980
EMC-M-180, T3 UPTAKE - 100 TUBES
K800188 · KHQ
Endocrine-Metabolic Center
Chemistry · 15d
Cleared Feb 13, 1980
BOVINE ALBUMIN 22% & 30% SOLUTIONS
K800189 · KSG
Gotham Biologics, Inc.
Chemistry · 15d
Cleared Feb 13, 1980
STANBIO DIRECT URIC ACID TEST SET #0770
K800190 · CDH
Stanbio Laboratory
Chemistry · 15d
Cleared Feb 11, 1980
MICRO ELISA MINI READER
K800057 · JJQ
Dynatech Laboratories, Inc.
Chemistry · 32d
Cleared Feb 11, 1980
PIPET CALIBRATION KIT
K800062 · JIS
Streck Laboratories, Inc.
Chemistry · 31d
Cleared Feb 11, 1980
CENTRIFICHEM ALP/ALKALINE PHOSPHATASE
K800131 · CJE
Union Carbide Corp.
Chemistry · 24d
Cleared Feb 05, 1980
KODAK EKTACHEM ELECTROLYTE ANALYZER
K800054 · CEM
Eastman Kodak Company
Chemistry · 27d
Cleared Feb 05, 1980
ASI REAGENT
K800065 · CIT
Gilford Diagnostics
Chemistry · 25d
Cleared Feb 05, 1980
GLUCOSE OXIDASE REAGENT KIT
K800070 · CGA
Fisher Scientific Co., LLC
Chemistry · 25d
Cleared Feb 05, 1980
BUN REAGENT KIT
K800071 · CDS
Fisher Scientific Co., LLC
Chemistry · 25d
Cleared Feb 01, 1980
MICROPITETTE
K792696 · JRC
Meridian Diagnostics, Inc.
Chemistry · 36d