FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,224 results
10489–10512 of 13,224
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jun 16, 1983
PH 6.838 REF. BUFFER
K831019 · CHL
Fisher Scientific Co., LLC
Chemistry · 78d
Cleared Jun 16, 1983
CALIBRATING SOLUTION FOR ABL-1 & 2
K831021 · CHL
Fisher Scientific Co., LLC
Chemistry · 78d
Cleared Jun 16, 1983
ELECTROLYTE PO2 FOR OXYGEN ELECTRODES
K831024 · CHL
Fisher Scientific Co., LLC
Chemistry · 78d
Cleared Jun 16, 1983
ELECTROLYLE CARBON DIOXIDE ELECTRODES
K831025 · CHL
Fisher Scientific Co., LLC
Chemistry · 78d
Cleared Jun 16, 1983
DAC-CEL PTH KIT RD51
K831069 · CEW
Wellcome Diagnostics
Chemistry · 73d
Cleared Jun 16, 1983
COLORIMETRIC BUN
K831414 · CDL
Bio-Analytics Laboratories, Inc.
Chemistry · 45d
Cleared Jun 16, 1983
LACTIC DEHYDROGENASE REAGENT SET
K831415 · CFJ
Sterling Biochemical, Inc.
Chemistry · 45d
Cleared Jun 16, 1983
RAICHEM LDH-P REAGENT W/SEPARATE START-
K831419 · CFJ
Reagents Applications, Inc.
Chemistry · 44d
Cleared Jun 15, 1983
WHITE BLOOD CELL CONTROL
K830864 · JPK
Control Diagnostics
Chemistry · 89d
Cleared Jun 15, 1983
REFERENCE BUFFER PH 7.382
K831023 · CHL
Fisher Scientific Co., LLC
Chemistry · 77d
Cleared Jun 08, 1983
LIPOSOL
K830472 · JKA
Quest Medical, Inc.
Chemistry · 113d
Cleared Jun 08, 1983
DIAGNOSTICS PCO2 ELECTROLYTE W/CARBON
K831012 · CHL
Fisher Scientific Co., LLC
Chemistry · 70d
Cleared Jun 08, 1983
DIAGNOSTICS PO 2 ELECTROLYTE
K831013 · CHL
Fisher Scientific Co., LLC
Chemistry · 70d
Cleared Jun 08, 1983
BHCG RIA KIT
K831264 · JHI
Micromedic Systems
Chemistry · 51d
Cleared Jun 08, 1983
PROTOTRO/PROTEOLYTIC ENZYME CONTROL
K831297 · JBQ
American Dade
Chemistry · 48d
Cleared Jun 08, 1983
PBI BHCG RIA KIT
K831302 · JHI
Pacific Biotech, Inc.
Chemistry · 48d
Cleared Jun 08, 1983
RIANEN PROLACTIN 125I KIT
K831345 · CFT
New England Nuclear
Chemistry · 44d
Cleared Jun 08, 1983
ASTRA SYSTEMS ENZYME MODULE
K831353 · CFJ
Beckman Instruments, Inc.
Chemistry · 43d
Cleared Jun 08, 1983
LINEAR ENZMATIC URIC ACID SYSTEM
K831398 · KNK
Simmler, Inc.
Chemistry · 40d
Cleared Jun 08, 1983
PHADEBAS & PHADEZYM RAST ALLERGEN DISCS
K831442 · DHB
Pharmacia, Inc.
Chemistry · 34d
Cleared Jun 08, 1983
SPIA SYS FOR SOLID PHASE IMMUNOASSAYS
K831448 · LIB
R&D Systems, Inc.
Chemistry · 34d
Cleared Jun 02, 1983
IP SPECIFIC G
K830005 · DAA
Diagnostic Reagent Tech.
Chemistry · 150d
Cleared Jun 02, 1983
B-CLONE HCG ASSAY
K831155 · JHJ
Monoclonal Antibodies, Inc.
Chemistry · 55d
Cleared Jun 02, 1983
RIAGEN B-HCG RIA KIT
K831221 · JHI
Biogenex Laboratories
Chemistry · 48d