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
12049–12072 of 13,249
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jan 29, 1980
URIC ACID KIT
K792545 · KNK
Alta Diagnostics, Inc.
Chemistry · 50d
Cleared Jan 29, 1980
AGAROSE BARBITAL BUFFER
K792547 · JJN
Electrophoresis Corp. of America
Chemistry · 50d
Cleared Jan 29, 1980
ALKALINE PHOSPHATASE MARKER
K792548 · CIN
Electrophoresis Corp. of America
Chemistry · 50d
Cleared Jan 29, 1980
ALKALINE PHOSPHATASE REAGENT
K792551 · CJH
Electrophoresis Corp. of America
Chemistry · 50d
Cleared Jan 29, 1980
AGAROSE BARBITAL-EDTA BUFFER
K792553 · JJN
Electrophoresis Corp. of America
Chemistry · 50d
Cleared Jan 29, 1980
H-I-M-TEST FOR DETECTING HUMAN CHOR. GON
K800055 · JHJ
Technam, Inc.
Chemistry · 19d
Cleared Jan 23, 1980
QUANTIMUNE CORTISOL RIA CORTISOL RADIO-
K800045 · CGR
Bio-Rad
Chemistry · 15d
Cleared Jan 23, 1980
DELTA TEST AMYLASE UV
K800049 · JFJ
Bd Becton Dickinson Vacutainer...
Chemistry · 14d
Cleared Jan 23, 1980
KODAK EKTACHEM FOUR CHEMISTRY ANALYZER
K800053 · JJE
Eastman Kodak Company
Chemistry · 14d
Cleared Jan 21, 1980
CENTRIA FSH RIA
K792233 · CGJ
Union Carbide Corp.
Chemistry · 77d
Cleared Jan 21, 1980
BLOOD FLUID FILTERS
K792723 · JKA
Dade, Baxter Travenol Diagnostics, Inc.
Chemistry · 21d
Cleared Jan 21, 1980
DUPONT ACA ION SELECTIVE ELECTRODE
K800016 · CEM
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 14d
Cleared Jan 21, 1980
WORTHINGTON FLOZYME* CPK (340NM)
K800028 · JHS
Worthington Diagnostic Systems
Chemistry · 14d
Cleared Jan 21, 1980
PENTEX LIPOPROTEIN CHOLESTEROL SOLU.
K800035 · JJX
Miles Laboratories, Inc.
Chemistry · 14d
Cleared Jan 21, 1980
TOTAL ESTRIOL RIA KIT
K800036 · CGI
Amersham Corp.
Chemistry · 14d
Cleared Jan 21, 1980
ALT REAGENT
K800038 · CKA
Gilford Diagnostics
Chemistry · 14d
Cleared Jan 21, 1980
LITHIUM DILUENT (1500 MM/E)
K800039 · JIH
Gilford Diagnostics
Chemistry · 14d
Cleared Jan 21, 1980
SODIUM/POTASSIUM (100/100 MEQ/E)
K800040 · JIX
Gilford Diagnostics
Chemistry · 14d
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