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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,231 results
12049–12072 of 13,231
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jan 21, 1980
SODIUM/POTASSIUM 140/5 MEQ/L)
K800041 · JIX
Gilford Diagnostics
Chemistry · 14d
Cleared Jan 21, 1980
LITHIUM STANDARD (1MM/L)
K800042 · JIS
Gilford Diagnostics
Chemistry · 14d
Cleared Jan 21, 1980
CESIUM DILUENT (1.5 MM/L)
K800043 · JIX
Gilford Diagnostics
Chemistry · 14d
Cleared Jan 17, 1980
ANALYTE CORTISOL
K792439 · CGR
Technicon Instruments Corp.
Chemistry · 50d
Cleared Jan 17, 1980
VENOJECT AUTOSEP
K792587 · JKA
Kimble-Terumo, Inc.
Chemistry · 31d
Cleared Jan 17, 1980
COBAS-BLO REAGENTS (LACTATE DEHYDRO
K792658 · CFJ
Hoffmann-La Roche, Inc.
Chemistry · 22d
Cleared Jan 17, 1980
AUTOPAK-12 UPTAKE TEST DELIVERY SYSTEM
K792662 · KHQ
Micromedic Systems
Chemistry · 22d
Cleared Jan 17, 1980
COBAS-BIO CENTRIFUGAL ANALYZER
K792671 · JJG
Hoffmann-La Roche, Inc.
Chemistry · 21d
Cleared Jan 16, 1980
CENTRIA LH RIA
K792350 · CEP
Union Carbide Corp.
Chemistry · 58d
Cleared Jan 16, 1980
RIA-QUANT CK-MB TEST KIT
K792504 · JHX
Mallinckrodt Critical Care
Chemistry · 43d
Cleared Jan 16, 1980
CK-MB (CREATINE KINASE-MB) RIA CONTROL
K792524 · JJX
Mallinckrodt Critical Care
Chemistry · 41d
Cleared Jan 16, 1980
NEOCHROME II GLUCOSE, #4044
K792534 · CGA
American Monitor Corp.
Chemistry · 40d
Cleared Jan 16, 1980
TRIIODOTHYRONINE RIA SYSTEM
K792539 · CDP
Radioimmunoassay, Inc.
Chemistry · 37d
Cleared Jan 16, 1980
ELVI MUCAPROTEINS
K792554 · JQN
Volu Sol Medical Industries
Chemistry · 37d
Cleared Jan 16, 1980
ELVI NON-ESTERIFIED FATTY ACIDS
K792555 · JLH
Volu Sol Medical Industries
Chemistry · 37d
Cleared Jan 16, 1980
IMMUNOSTAT TSH TEST
K792562 · JLW
Meloy Laboratories, Inc.
Chemistry · 35d
Cleared Jan 16, 1980
TIPSEP-T4(RIA) T4 RADIOIMMUNOASSAY
K792599 · CDX
Nuclear Diagnostics, Inc.
Chemistry · 29d
Cleared Jan 16, 1980
CHLORIDE REAGENT
K792605 · CHJ
Gilford Diagnostics
Chemistry · 29d
Cleared Jan 16, 1980
T3 UPTAKE (T3U) REAGENTS
K792607 · KHQ
Dade, Baxter Travenol Diagnostics, Inc.
Chemistry · 29d
Cleared Jan 16, 1980
LEECO P.A.P. QUANT. DIAGNOSTIC KIT
K792652 · JFH
Leeco Diagnostics, Inc.
Chemistry · 26d
Cleared Jan 16, 1980
SENSI-SLIDE
K792657 · JHJ
Hoffmann-La Roche, Inc.
Chemistry · 21d
Cleared Jan 11, 1980
CHEMISTRY ANALYZER REAGENTS
K792482 · CIX
Laboratory Products, Inc.
Chemistry · 53d
Cleared Jan 11, 1980
ACA HIGH DENSITY LIPOPROTEIN CHOLES.
K792509 · CHH
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 37d
Cleared Jan 11, 1980
SANDARE CHLORIDE PROCEDURE
K792531 · CHJ
Sandare Chemical Co., Inc.
Chemistry · 35d