FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,237 results
6241–6264 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Apr 29, 1992
LYPHOCHEK(R) FRUCTOSAMINE CONTROL
K921089 · JJX
Bio-Rad
Chemistry · 54d
Cleared Apr 29, 1992
HCG CONTROL
K921206 · JJX
Polymedco, Inc.
Chemistry · 47d
Cleared Apr 29, 1992
ACA LACTATE DEHYDROGENASE ISOENZYME 1 (LD1) METHOD
K921455 · CFE
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 33d
Cleared Apr 29, 1992
VACUTAINER(R) BRAND SAFETY-LOK BLOOD COLLECT SET
K921636 · GIM
Bd Becton Dickinson Vacutainer...
Chemistry · 23d
Cleared Apr 29, 1992
VACUTAINER(R) BRAND SST(R) AND CAT TUBES
K921806 · JKA
Bd Becton Dickinson Vacutainer...
Chemistry · 14d
Cleared Apr 22, 1992
MYDAS(TM)-MB2/MYDAS(TM)-MB
K913380 · JHX
Intl. Immunoassay Laboratories, Inc.
Chemistry · 268d
Cleared Apr 22, 1992
SLT SPECTRA
K915689 · JJQ
Slt Labinstruments, Inc.
Chemistry · 121d
Cleared Apr 22, 1992
SLT 340 ATTC
K915690 · JJQ
Slt Labinstruments, Inc.
Chemistry · 121d
Cleared Apr 17, 1992
T4 EIA BEAD ASSAY
K920766 · CDX
Tech-Co, Inc.
Chemistry · 58d
Cleared Apr 17, 1992
KING DIAGNOSTICS SODIUM/POTASSIUM STANDARD
K920809 · JIS
King Diagnostics, Inc.
Chemistry · 56d
Cleared Apr 17, 1992
AMERLITE FREE THYROID CONTROL SERA LAN.4002
K920940 · JJY
Eastman Kodak Company
Chemistry · 50d
Cleared Apr 14, 1992
ULTRA+ BLOOD GLUCOSE TEST STRIP
K915770 · CGA
Home Diagnostics, Inc.
Chemistry · 112d
Cleared Apr 14, 1992
DIASCAN BLOOD GLUCOSE MONITORING TEST STRIP
K915772 · CGA
Home Diagnostics, Inc.
Chemistry · 112d
Cleared Apr 08, 1992
ELISA TUBE LH TEST KIT
K920920 · CEP
Bio Clinic Co.
Chemistry · 40d
Cleared Apr 08, 1992
ELISA TUBE PROLACTIN TEST KIT
K920921 · CFT
Bio Clinic Co.
Chemistry · 40d
Cleared Apr 08, 1992
PRECISE CHROMATOGRAPHIC IMMUNOASSAY FOR HCG
K921012 · LCX
Bd Becton Dickinson Vacutainer...
Chemistry · 36d
Cleared Apr 08, 1992
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM
K921176 · CEP
Vitek Systems, Inc.
Chemistry · 28d
Cleared Apr 07, 1992
HUMAN CHORIONIC GONADATROPHIN AND UNCON. ESTRIOL
K920826 · JJY
Eastman Kodak Company
Chemistry · 43d
Cleared Apr 07, 1992
TMB CHROMOGEN/SUBSTRATE REAGENT SET
K920918 · JHI
Bio Clinic Co.
Chemistry · 39d
Cleared Mar 27, 1992
SEX CRIMES/SEX ASSAULT VICT/SUSPECT EVID COLL KITS
K915814 · JKA
Sirchie Finger Print Laboratories, Inc.
Chemistry · 88d
Cleared Mar 27, 1992
MEDIX BIOTECH THROXINE ENZYME IMMUNOASSAY TEST KIT
K920712 · KLI
Medix Biotech, Inc.
Chemistry · 38d
Cleared Mar 27, 1992
AMYLASE REAGENT
K921057 · JFJ
Genzyme Corp.
Chemistry · 22d
Cleared Mar 26, 1992
VENTREX COATED TUBE HIGH SENSIT. TSH RADIOIMMUNOAS
K920856 · JLW
Hycor Biomedical, Inc.
Chemistry · 37d
Cleared Mar 26, 1992
ELISA TUBE FSH TEST KIT ENZYME LINKED IMMUN. ASSAY
K920917 · CGJ
Bio Clinic Co.
Chemistry · 27d