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
11281–11304 of 13,224
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Oct 09, 1981
LDH REAGENT SET
K812836 · CFH
Anco Medical Reagents & Assoc.
Chemistry
Cleared Oct 06, 1981
RIA QUANT C-PEPTIDE KIT
K812689 · JKD
Mallinckrodt Critical Care
Chemistry · 14d
Cleared Oct 06, 1981
C-PEPTIDE CONTROL PACK
K812690 · JJX
Mallinckrodt Critical Care
Chemistry · 14d
Cleared Oct 06, 1981
AMYLASE
K812699 · KHM
Pointe Scientific, Inc.,
Chemistry · 14d
Cleared Oct 02, 1981
ULTRA ZYME PLUS CK-1 #64978, 65027 & 28
K812593 · CGS
Harleco
Chemistry · 21d
Cleared Oct 02, 1981
ULTRA ZYME PLUS AMYL #64982 & 65031
K812594 · CIJ
Harleco
Chemistry · 21d
Cleared Oct 02, 1981
SQC BUFFER
K812601 · JJS
Transidyne General Corp.
Chemistry · 18d
Cleared Oct 02, 1981
BIOVATION URINALYSIS REPORTER
K812604 · JQP
Biovation, Inc.
Chemistry · 17d
Cleared Oct 02, 1981
QUANTICOAT NEONATAL 125 T4 RADIOIMMUNO
K812611 · CDP
Kallestad Laboratories, Inc.
Chemistry · 17d
Cleared Oct 02, 1981
VITROGEN TM 100
K812617 · KIT
Collagen Corp.
Chemistry · 17d
Cleared Oct 02, 1981
ANEMIA CONTROL
K812635 · JJY
Environmental Chemical Specialties
Chemistry · 17d
Cleared Oct 02, 1981
URIC ACID REAGENT-ENZYMATIC-COLOR-520 NM
K812641 · KNK
Reagents Applications, Inc.
Chemistry · 16d
Cleared Oct 02, 1981
EMIT AUTO CAROUSEL
K812647 · JQW
Syva Co.
Chemistry · 15d
Cleared Oct 02, 1981
THYROXINE (T4) 125I
K812666 · CDP
Pcl-Ria, Inc.
Chemistry · 11d
Cleared Oct 02, 1981
SANDARE FAST 340 PHOSPHORUS PROCEDURE
K812670 · CED
Sandare Chemical Co., Inc.
Chemistry · 11d
Cleared Oct 02, 1981
EMBRITROL CK-MB CONTROLS
K812671 · JJT
Intl. Immunoassay Laboratories, Inc.
Chemistry · 11d
Cleared Oct 02, 1981
UNITEST-POTASSIUM
K812677 · CEJ
Biodynamics Corp.
Chemistry · 10d
Cleared Sep 29, 1981
ULTRA CHEM E-GLU #64976 & 65040
K812595 · CFR
Harleco
Chemistry · 18d
Cleared Sep 29, 1981
ULTRA ZYME PLUS ALP #64962, 65029 & 30
K812596 · CJE
Harleco
Chemistry · 18d
Cleared Sep 24, 1981
LACTIC ACID DIALYSATE ADDITIVE
K811706 · KPO
Edlaw Pharmaceuticals, Inc.
Chemistry · 100d
Cleared Sep 24, 1981
GAMMACOAT (125) INSULIN RADIOIMMUNOASSAY
K812227 · CFP
Clinical Assays, Inc.
Chemistry · 45d
Cleared Sep 24, 1981
HDL CHOLESTEROL REAGENT
K812574 · LBR
Pointe Scientific, Inc.,
Chemistry · 15d
Cleared Sep 24, 1981
BOVINE CHEMISTRY CONTROL I.X. & II.X.
K812583 · JJY
American Dade
Chemistry · 14d
Cleared Sep 24, 1981
ULTRA CHEM E-TRIG #65024
K812589 · CDT
Harleco
Chemistry · 13d