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
3601–3624 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jun 16, 2000
ABSOLUTE HCG PREGNANCY TEST
K000844 · DHA
Mizuho USA, Inc.
Chemistry · 93d
Cleared Jun 09, 2000
DELFIA NEONATAL IRT KIT
K993697 · CGZ
Wallac OY
Chemistry · 220d
Cleared Jun 02, 2000
SYNCHRON CONTROL
K001458 · JJX
Beckman Coulter, Inc.
Chemistry · 23d
Cleared Jun 02, 2000
MODIFICATION TO FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM
K001427 · CGA
Selfcare, Inc.
Chemistry · 28d
Cleared Jun 02, 2000
AMMONIA-L3K ASSAY, MODEL 263-17, AMMONIA-L3K ASSAY, MODEL 263-30
K001285 · JIF
Diagnostic Chemicals , Ltd.
Chemistry · 42d
Cleared Jun 01, 2000
WAKO HDL-C/LDL-C CALIBRATOR
K001005 · JIS
Wako Chemicals USA, Inc.
Chemistry · 64d
Cleared Jun 01, 2000
WAKO APOLIPOPROTEIN HIGH LEVEL CALIBRATOR
K001004 · JIS
Wako Chemicals USA, Inc.
Chemistry · 64d
Cleared May 25, 2000
LIQUICHEK IMMUNOASSAY PLUS CONTROL, MODEL 360, 361, 362, 363
K001373 · JJY
Bio-Rad
Chemistry · 24d
Cleared May 24, 2000
BIOSCANNER TRIGLYCERIDES TEST STRIPS
K991894 · JGY
Polymer Technology Systems, Inc.
Chemistry · 356d
Cleared May 24, 2000
WAKO LIPASE CALIBRATOR
K001002 · JIS
Wako Chemicals USA, Inc.
Chemistry · 56d
Cleared May 24, 2000
ATAC PAK BUN REAGENT AND ATAC CALIBRATOR KITS
K000958 · CDQ
Elan Holdings, Inc.
Chemistry · 61d
Cleared May 18, 2000
BAYER ADVIA IMS SYSTEM
K000921 · DER
Bayer Corp.
Chemistry · 57d
Cleared May 18, 2000
ADDITIONAL ASSAYS FOR BAYER ADVIA IMS SYSTEM
K000903 · KLT
Bayer Corp.
Chemistry · 58d
Cleared May 18, 2000
THE CARDIAC READER SYSTEM
K000784 · MMI
Roche Diagnostics Corp.
Chemistry · 69d
Cleared May 17, 2000
ATAC PAK GLUCOSE REAGENT AND ATAC CALIBRATOR KITS
K000556 · CFR
Elan Diagnostics
Chemistry · 89d
Cleared May 17, 2000
IMMAGE IMMUNOCHEMISTRY SYSTEM LIPOPROTEIN(A) LPAX REAGENT, ARRAY SYSTEM...
K000121 · DFC
Beckman Coulter, Inc.
Chemistry · 120d
Cleared May 15, 2000
BVBLUE
K993732 · MXB
Gryphus Diagnostics, LLC
Chemistry · 193d
Cleared May 15, 2000
EASYELECTROLYTE ANALYZER AND RAPIDLYTE ANALYZER
K000926 · CGZ
Medica Corp.
Chemistry · 54d
Cleared May 05, 2000
CONNECT DATA MANAGEMENT SYSTEM
K994433 · LFR
Abbott Diabetes Care, Inc.
Chemistry · 127d
Cleared May 05, 2000
VITROS CHEMISTRY PRODUCTS CREA SLIDE, VIRTROS CHEMISTRY PRODUCTS CALIBRATOR...
K001310 · JFY
Ortho-Clinical Diagnostics, Inc.
Chemistry · 10d
Cleared May 04, 2000
DIRECT TIBC CALIBRATOR
K000783 · JIT
Reference Diagnostics, Inc.
Chemistry · 55d
Cleared May 02, 2000
VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE REAGENT PACK 1/2, VITAMIN B12/FOLATE...
K001266 · CGN
Ortho-Clinical Diagnostics, Inc.
Chemistry · 12d
Cleared May 02, 2000
ATAC PAK CHOLESTEROL REAGENT AND ATAC CALLIBRATOR KITS
K000900 · CHH
Elan Holdings, Inc.
Chemistry · 42d
Cleared May 02, 2000
DIRECT TIBC KIT
K000781 · JMO
Reference Diagnostics, Inc.
Chemistry · 53d