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
13177–13200 of 13,231
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Oct 29, 1976
REAGENT, ALBUMIN DETERMINATION
K760473 · CIX
Simmler & Son, Inc.
Chemistry · 73d
Cleared Oct 29, 1976
REAGENT, ALKALINE PHOSPHATASE DETERM.
K760474 · CJE
Simmler & Son, Inc.
Chemistry · 73d
Cleared Oct 29, 1976
REAGENT, CALCIUM DETERMINATION
K760475 · CIC
Simmler & Son, Inc.
Chemistry · 73d
Cleared Oct 29, 1976
REAGENTS-4 FOR URIC ACID DETERMINATION
K760477 · CDH
Simmler & Son, Inc.
Chemistry · 73d
Cleared Oct 29, 1976
REAGENT, BUN (UREA NITROGEN) DETERM.
K760478 · CDW
Simmler & Son, Inc.
Chemistry · 73d
Cleared Oct 29, 1976
REAGENT, TOTAL BILIRUBIN DETERMINATION
K760479 · CIG
Simmler & Son, Inc.
Chemistry · 73d
Cleared Oct 29, 1976
REAGENT, TOTAL PROTEIN DETERMINATION
K760480 · CEK
Simmler & Son, Inc.
Chemistry · 73d
Cleared Oct 29, 1976
SIGMA PROCEDURE NO. 745 - EP.REAGENT SY
K760591 · JHX
Sigma Chemical Co.
Chemistry · 52d
Cleared Oct 29, 1976
CLINICAL SPECTROPHOTOMETER
K760672 · JJQ
The Dow Chemical Co.
Chemistry · 39d
Cleared Oct 28, 1976
HEMAFLOUR ZP
K760506 · KHO
Buchler Instruments, Inc.
Chemistry · 66d
Cleared Oct 27, 1976
TEST, LACTATE DEHYDROGENASE
K760345 · CFJ
Princeton Biomedix
Chemistry · 86d
Cleared Oct 27, 1976
ASSAY FOR GAMMA GLUTAMYLTRANSFERASE
K760346 · JPZ
Princeton Biomedix
Chemistry · 86d
Cleared Oct 27, 1976
REAGENT SYSTEM, SIGMA PROCEDURE NO. 270
K760348 · CCZ
Sigma Chemical Co.
Chemistry · 86d
Cleared Oct 21, 1976
REFEREE AQUEOUS TRIGLYCERIDE STND
K760806 · JIS
Analytical Products, Inc.
Chemistry · 9d
Cleared Oct 21, 1976
REAGENT SYSTEM
K760821 · CJT
Sigma Chemical Co.
Chemistry · 8d
Cleared Oct 08, 1976
STERILE TUBULAR UNBLEACHED STOCKINETTE
K760750 · JLG
Dennison Manufacturing Co.
Chemistry · 7d
Cleared Oct 05, 1976
SET, TRINDER GLUCOSE
K760347 · CGA
Princeton Biomedix
Chemistry · 64d
Cleared Oct 05, 1976
BILIRUBIN REF., SIGMA STOCK NO. 605-10
K760349 · JIT
Sigma Chemical Co.
Chemistry · 64d
Cleared Oct 05, 1976
TEST, SEROSONIC ALBUMIN
K760355 · CIX
Mallinckrodt Critical Care
Chemistry · 64d
Cleared Sep 27, 1976
DETECTOR, MODEL LC-100 FLUORESCENCE
K760261 · KHO
The Perkin-Elmer Corp.
Chemistry · 70d
Cleared Sep 21, 1976
ULTRAZYME AMYLASE
K760026 · CIJ
Harleco
Chemistry · 99d
Cleared Sep 15, 1976
CPK - ISOENZYMES
K760028 · JHT
Harleco
Chemistry · 93d
Cleared Sep 15, 1976
ENZYMATIC TRIGLYCERIDE
K760029 · CDT
Harleco
Chemistry · 93d
Cleared Sep 13, 1976
CLINICARD PHOSPHORUS
K760030 · CEO
Harleco
Chemistry · 91d