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
11353–11376 of 13,224
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Aug 13, 1981
GILCHEM CREATININE REAGENT
K812109 · CGX
Gilford Diagnostics
Chemistry · 17d
Cleared Aug 13, 1981
GILCHEM CALCIUM REAGENT
K812110 · CIC
Gilford Diagnostics
Chemistry · 17d
Cleared Aug 13, 1981
MARRIA-HPRL RIA KIT
K812112 · CFT
Intl. Immunoassay Laboratories, Inc.
Chemistry · 17d
Cleared Aug 13, 1981
AMERLEX TSH RIA KIT
K812136 · JLW
Amersham Corp.
Chemistry · 16d
Cleared Aug 12, 1981
SICKLE CELL REAGENT SET
K811828 · GHM
Anco Medical Reagents & Assoc.
Chemistry · 44d
Cleared Aug 12, 1981
WAKO NEFA C TEST
K812081 · JLG
Wako Chemicals USA, Inc.
Chemistry · 21d
Cleared Aug 12, 1981
FAST CHOLES-CINET
K812091 · CHH
Sclavo, Inc.
Chemistry · 20d
Cleared Aug 12, 1981
SERALYZER
K812100 · CHH
Miles Laboratories, Inc.
Chemistry · 19d
Cleared Aug 03, 1981
OREIA II, B-HCG
K811940 · JHJ
Organon, Inc.
Chemistry · 28d
Cleared Aug 03, 1981
RADIOIMMUNOASSAY, FOLLICLE STIMULATING
K811993 · CGJ
Endocrine-Metabolic Center
Chemistry · 20d
Cleared Aug 03, 1981
KODAK EKTACHEM CLIN. CHEM. SLIDES (AMYL)
K812027 · CIW
Eastman Kodak Company
Chemistry · 14d
Cleared Aug 03, 1981
KODAK EKTACHEM CLIN. CHEM. SLIDES (TP)
K812028 · CEK
Eastman Kodak Company
Chemistry · 14d
Cleared Aug 03, 1981
KODAK EKTACHEM CLIN. CHEM. SLIDES (TRIG)
K812029 · CDT
Eastman Kodak Company
Chemistry · 14d
Cleared Aug 03, 1981
KODAK EKTACHEM CLIN. CHEM. SLIDES (ALB)
K812030 · CIX
Eastman Kodak Company
Chemistry · 14d
Cleared Jul 31, 1981
SIGMA PROCEDURE 265-UV
K811864 · CED
Sigma Chemical Co.
Chemistry · 30d
Cleared Jul 28, 1981
GASTRIN RIA DIAGNOSTIC KIT
K812004 · CGC
Abbott Laboratories
Chemistry · 14d
Cleared Jul 27, 1981
ARACHIDONIC ACID
K811290 · JBX
Bio/Data Corp.
Chemistry · 77d
Cleared Jul 27, 1981
NEOCEPT
K811941 · JHJ
Organon, Inc.
Chemistry · 21d
Cleared Jul 27, 1981
COMBO-FER IRON DIAGNOSTIC
K811954 · JQG
Immuno Assay Corp.
Chemistry · 19d
Cleared Jul 27, 1981
RADIOIMMUNOASSAY LUTEINIZING HORMONE
K811994 · CEP
Endocrine-Metabolic Center
Chemistry · 13d
Cleared Jul 27, 1981
A-GENT THEOPHYLLINE
K812003 · KLS
Abbott Laboratories
Chemistry · 13d
Cleared Jul 24, 1981
PLA-MATE
K803071 · GKL
Labex, Inc.
Chemistry · 231d
Cleared Jul 23, 1981
ACCUDEX
K811680 · JJQ
Biodynamics Corp.
Chemistry · 38d
Cleared Jul 23, 1981
ESKAFLOW TEST FOR TRIGLYCERIDES
K811850 · CDT
Smithkline Diagnostics, Inc.
Chemistry · 22d