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
10705–10728 of 13,224
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jan 05, 1983
DOUBLE ANTIBODY TSH I-125 RADIOIMMUNO
K823688 · JLW
Corning Medical & Scientific
Chemistry · 29d
Cleared Jan 05, 1983
ADVANCE SYSTEM EMITAED ANTIEPILEPTIC
K823740 · DKB
Syva Co.
Chemistry · 23d
Cleared Dec 30, 1982
GAMMA DAB[125I]PTH RADIOIMMUNOASSAY KIT
K822944 · CEW
Travenol Laboratories, S.A.
Chemistry · 87d
Cleared Dec 30, 1982
ENZYMATIC GLUCOSE DETERMINATION
K823474 · CGA
The Dow Chemical Co.
Chemistry · 38d
Cleared Dec 30, 1982
IMMUNOGLOBULIN CONTROL
K823566 · CZP
Syva Co.
Chemistry · 27d
Cleared Dec 28, 1982
CORDIA CMV
K823123 · LFZ
Cordis Corp.
Chemistry · 67d
Cleared Dec 28, 1982
IMMOPHASE TM HPL RADIOIMMUNOASSAY
K823292 · JMF
Corning Medical & Scientific
Chemistry · 53d
Cleared Dec 28, 1982
ALKPHOR SYSTEM
K823445 · CIN
California Immuno Diagnostic, Inc.
Chemistry · 42d
Cleared Dec 28, 1982
SINGLE VIAL AMYLASE PNP TEST
K823462 · JFJ
Boehringer Mannheim Corp.
Chemistry · 39d
Cleared Dec 28, 1982
ULTRA CHEM BAN-UV #65080 & 65081
K823472 · CDQ
Emd Chemicals, Inc.
Chemistry · 36d
Cleared Dec 28, 1982
GAMMADAB LH RADIO-KIT #CA-1508
K823476 · CEP
Clinical Assays, Inc.
Chemistry · 36d
Cleared Dec 28, 1982
TANDEM-E -IGE IMMUNOEZYMETRIC ASSAY
K823507 · DGC
Hybritech, Inc.
Chemistry · 34d
Cleared Dec 28, 1982
REMOVAWELL PLATE LID
K823557 · LIB
Dynatech Corp.
Chemistry · 26d
Cleared Dec 28, 1982
CORNING 170 PH/BLOOD GAS ANALYZER
K823570 · CHL
Corning Medical & Scientific
Chemistry · 25d
Cleared Dec 26, 1982
ULTRACHEM BUN-UV-GEM SAEC APPLI.#65080&
K823402 · CDQ
Emd Chemicals, Inc.
Chemistry · 41d
Cleared Dec 22, 1982
TITAN GEL LDH ISOENZYME KIT
K821983 · CEX
Helena Laboratories
Chemistry · 169d
Cleared Dec 22, 1982
RIASET PROLACTIN RIA KIT
K823304 · CFT
Immulok, Inc.
Chemistry · 47d
Cleared Dec 22, 1982
IN VITRO GAMMACOAT B-HCG RADIO. TEST
K823313 · JHI
Clinical Assays, Inc.
Chemistry · 47d
Cleared Dec 22, 1982
TRIGLYCERIDES REAGENT SET TAG-GK
K823341 · CDT
Sterling Biochemical, Inc.
Chemistry · 44d
Cleared Dec 22, 1982
ULTRACHEM ENZYMATIC CHOLESTEROL OXIDASE
K823354 · CHH
Emd Chemicals, Inc.
Chemistry · 47d
Cleared Dec 22, 1982
125-I FSH RADIOIMMUNOASSAY KIT
K823379 · CGJ
Clinetics Corp.
Chemistry · 40d
Cleared Dec 22, 1982
125-I LH RADIOIMMUNOASSAY KIT
K823380 · CEP
Clinetics Corp.
Chemistry · 40d
Cleared Dec 22, 1982
SOPHEIA GENTAMICIN EIA KIT
K823387 · LCD
Diagnostic Products Corp.
Chemistry · 37d
Cleared Dec 20, 1982
URIC ACID REAGENT
K822913 · KNK
Ac Biochemical Laboratories, Inc.
Chemistry · 80d