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
11953–11976 of 13,249
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Apr 21, 1980
ALDOCTK-125
K800775 · CJM
Sorin Biomedica, Fiat, USA, Inc.
Chemistry · 14d
Cleared Apr 21, 1980
TESTOK-125
K800776 · CDZ
Sorin Biomedica, Fiat, USA, Inc.
Chemistry · 14d
Cleared Apr 16, 1980
MICROMEDIC AUTOMATIC DILUTER
K800606 · JQW
Micromedic Systems
Chemistry · 30d
Cleared Apr 16, 1980
SMAC REPLACEMENT REAGENTS, WETTING AGENT
K800670
Diagnostic Solutions, Inc.
Chemistry · 21d
Cleared Apr 16, 1980
SMAC REPLACEMENT REAGENTS-WASH SOLUTIONS
K800671
Diagnostic Solutions, Inc.
Chemistry · 21d
Cleared Apr 16, 1980
STANBIO PROSTATIC ACID PHOSPHATASE TEST
K800693 · CKE
Stanbio Laboratory
Chemistry · 20d
Cleared Apr 16, 1980
AMERLEX CORTISOL RIA KIT
K800700 · CGR
Amersham Corp.
Chemistry · 19d
Cleared Apr 16, 1980
CODE QAS.105 PROLACTIN CONTROL SERA
K800708 · JJX
Amersham Corp.
Chemistry · 16d
Cleared Apr 16, 1980
PROLACTIN RIA KIT
K800740 · CFT
Amersham Corp.
Chemistry · 13d
Cleared Apr 10, 1980
HYDRAGAMMA 16
K800601 · JJJ
Innotron of Oregon, Inc.
Chemistry · 24d
Cleared Apr 10, 1980
CK ISOENZYME ELECTROPHORESIS CONTROL-I.D
K800604 · JJT
Beckman Instruments, Inc.
Chemistry · 24d
Cleared Apr 10, 1980
BUN REAGENT KIT #88108
K800616 · CDS
Hi Chem, Inc.
Chemistry · 23d
Cleared Apr 10, 1980
KODAK EKTACHEM CLINICAL CHEM. SLIDES
K800628 · JGS
Eastman Kodak Company
Chemistry · 21d
Cleared Apr 10, 1980
CENTRIFI CHEM AST/SGOT
K800641 · CIT
Union Carbide Corp.
Chemistry · 17d
Cleared Apr 04, 1980
TRANSPHOR TM LD LACTATE DEHYDROGENASE
K800568 · CFE
Corning Medical & Scientific
Chemistry · 22d
Cleared Apr 04, 1980
NSI CARBON DIOXIDE REAGENT KIT
K800586 · JFL
Nobel Scientific Industries, Inc.
Chemistry · 18d
Cleared Apr 04, 1980
NSI CALIBRATOR SET
K800588 · JIS
Nobel Scientific Industries, Inc.
Chemistry · 18d
Cleared Apr 04, 1980
GLUCOSE OXIDASE REAGENT
K800589 · CGA
Nobel Scientific Industries, Inc.
Chemistry · 18d
Cleared Apr 04, 1980
BUN KIT
K800590 · CDS
Nobel Scientific Industries, Inc.
Chemistry · 18d
Cleared Apr 04, 1980
VENTRE/SEP CORTISOL RIA
K800594 · CGR
Ventrex Laboratories, Inc.
Chemistry · 18d
Cleared Apr 02, 1980
SERALYZER REFLECTANCE PHOTOMETER/CALIB.
K800524 · CIE
Miles Laboratories, Inc.
Chemistry · 27d
Cleared Apr 02, 1980
LIPASE DETERMINATION
K800550 · CFG
The Dow Chemical Co.
Chemistry · 23d
Cleared Apr 02, 1980
KDA MICRO CHEMICAL ANALYZER
K800572 · JJE
American Monitor Corp.
Chemistry · 19d
Cleared Apr 02, 1980
NSI CREATININE KIT
K800583 · CGX
Nobel Scientific Industries, Inc.
Chemistry · 16d