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
11089–11112 of 13,224
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Apr 14, 1982
COLORIMETRIC LDH REAGENT SET
K820768 · CFH
Biorent Diagnostic, Inc.
Chemistry · 23d
Cleared Apr 09, 1982
GELMAN GLYCO-PHORE BUFFER
K820518 · JBD
Gelman Sciences, Inc.
Chemistry · 43d
Cleared Apr 09, 1982
AMERLEX LH RIA KIT (CODE IM2081)
K820753 · CEP
Amersham Corp.
Chemistry · 21d
Cleared Apr 08, 1982
MEM VITAMINS (100X
K820509 · KIT
Dutchland Laboratories, Inc.
Chemistry · 44d
Cleared Apr 06, 1982
QUANTIMUNE ESTRIOL RIA
K820728 · CGI
Bio-Rad
Chemistry · 20d
Cleared Apr 06, 1982
MR1 FOLLITROPIN RIA KIT
K820740 · CGJ
Microanalytic Research, Inc.
Chemistry · 19d
Cleared Apr 06, 1982
POLI-MAK MODEL F-4 (FINAL
K820748 · JJF
Pm America, Inc.
Chemistry · 18d
Cleared Apr 06, 1982
ENZYMUNE-TEST T4
K820750 · KLI
Icl Scientific
Chemistry · 18d
Cleared Apr 01, 1982
ROCHE B-HCG RIA
K820613 · JHI
Hoffmann-La Roche, Inc.
Chemistry · 24d
Cleared Apr 01, 1982
ROCHE B-HCG STANDARDS
K820614 · JHI
Hoffmann-La Roche, Inc.
Chemistry · 24d
Cleared Apr 01, 1982
CORNING 480 FLAME PHOTOMETER
K820631 · JJO
Corning Medical & Scientific
Chemistry · 24d
Cleared Apr 01, 1982
RAICHEM TM CREATINE KINASE REAGENT
K820644 · CGS
Reagents Applications, Inc.
Chemistry · 23d
Cleared Apr 01, 1982
EXHALED HYDROGEN MONITOR
K820652
Keymed, Inc.
Chemistry · 23d
Cleared Apr 01, 1982
BILIRUBIN(TOTAL) DETERMINATION CTMS
K820675 · CIG
The Dow Chemical Co.
Chemistry · 21d
Cleared Apr 01, 1982
LIQUISOL PROGESTERONE RADIOIMMUNO
K820686 · JLS
Damon Corp.
Chemistry · 21d
Cleared Apr 01, 1982
DUPONT AUTOMATIC CLINICAL ANALYZER
K820687 · JJE
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 21d
Cleared Apr 01, 1982
SYVA ADVANCE STANDARDIZATION KIT 01
K820698 · JIS
Syva Co.
Chemistry · 17d
Cleared Apr 01, 1982
EXTERNAL STANDARDS-SODIUMNPOTASSIUM
K820700 · JIX
Shaban Mfg. Co.
Chemistry · 17d
Cleared Apr 01, 1982
NOVA I FLUIDS PACK
K820701 · JIX
Shaban Mfg. Co.
Chemistry · 17d
Cleared Apr 01, 1982
GAS-TRAK 2 SYNTHETIC BLOOD GAS CONTROL
K820705 · JJS
United Diagnostics, Inc.
Chemistry · 16d
Cleared Apr 01, 1982
DOW BILIRUBIN(DIRECT) DETERMINATION
K820714 · CIG
The Dow Chemical Co.
Chemistry · 17d
Cleared Apr 01, 1982
COMPUTERIZED INTERPRETATION OF ARTERIAL
K820721 · JQP
Philip R. Corsello, M.D.
Chemistry · 16d
Cleared Apr 01, 1982
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDDE
K820722 · JHS
Eastman Kodak Company
Chemistry · 16d
Cleared Apr 01, 1982
KODAK EKTACHEM CLINICAL CHEM. NH3
K820723 · JID
Eastman Kodak Company
Chemistry · 16d