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
3241–3264 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Mar 26, 2002
1,25-DIHYDROXYVITAMIN D125I RIA
K014030 · MRG
DiaSorin, Inc.
Chemistry · 110d
Cleared Mar 23, 2002
CALIBRATING MATERIAL,CAL-PAK, CAL & SLOPE STANDARDS
K020596 · JIT
Diamond Diagnostics, Inc.
Chemistry · 29d
Cleared Mar 21, 2002
VALIDATE CHEM 8 CALIBRATION VERIFICATION TEST SET
K020450 · JJY
Maine Standards Co.
Chemistry · 38d
Cleared Mar 21, 2002
URS-IG (GLUCOSE TEST)
K020175 · JIL
Teco Diagnostics
Chemistry · 63d
Cleared Mar 21, 2002
DIABETES ASSISTANT SOFTWARE
K014139 · CGA
Roche Diagnostics Corp.
Chemistry · 94d
Cleared Mar 19, 2002
IMMUNOASSAY PLUS CONTROL, LEVELS 1, 2, AND 3
K020237 · JJY
Consolidated Technology
Chemistry · 55d
Cleared Mar 15, 2002
ACS:180 AND ADVIA CENTAUR IPTH IMMUNOASSAY
K020217 · JJX
Bayer Diagnostics Corp.
Chemistry · 52d
Cleared Mar 08, 2002
SAS VALUE HCG
K020438 · JHI
Sa Scientific, Inc.
Chemistry · 25d
Cleared Mar 08, 2002
MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONS
K013662 · JHO
Quantimetrix Corp.
Chemistry · 122d
Cleared Mar 08, 2002
LP(A)-LATEX SEIKEN ASSAY KIT
K013359 · DFC
Denka Seiken'S
Chemistry · 149d
Cleared Mar 01, 2002
MODIFICATION TO VIGIL LIPID CONTROL
K020521 · JJY
Beckman Coulter, Inc.
Chemistry · 10d
Cleared Mar 01, 2002
ACTIVE FREE BETA-HCG ELISA, MODEL DSL-10-8500
K020128 · JHI
Diagnostic Systems Laboratories, Inc.
Chemistry · 45d
Cleared Feb 28, 2002
JAS AMYLASE LIQUID REAGENT
K020282 · JFJ
Jas Diagnostics, Inc.
Chemistry · 31d
Cleared Feb 28, 2002
STAT PROFILE PHOX ANALYZER
K014295 · CHL
Nova Biomedical Corp.
Chemistry · 62d
Cleared Feb 28, 2002
SOF-TACT DIABETES MANAGEMENT SYSYEM
K012975 · NBW
Abbott Laboratories
Chemistry · 176d
Cleared Feb 19, 2002
LIBERTY BLOOD GLUCOSE MONITORING SYSTEM
K014167 · NBW
Polymedica Pharmaceuticals, U.S.A.,...
Chemistry · 62d
Cleared Feb 19, 2002
CLEARPLANE EASY OVULATION TEST
K013874 · CEP
Unipath , Ltd.
Chemistry · 90d
Cleared Feb 15, 2002
EXCELSIOR TEST STRIPS, FOR USE WITH THE HOME DIAGNOSTICS, INC.
K013342 · CGA
Chay Medical, LLC
Chemistry · 129d
Cleared Feb 12, 2002
HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEM
K020232 · CGA
Hypoguard USA, Inc.
Chemistry · 29d
Cleared Feb 08, 2002
TESTOSTERONE BY ENZYMEIMMUNOASSAY (EIA)
K014120 · CDZ
Diagnostics Biochem Canada, Inc.
Chemistry · 53d
Cleared Feb 08, 2002
OLYMPUS LDL CHOLESTEROL REAGENT, OLYMPUS LDL CHOLESTEROL CALIBRATOR, OLYMPUS...
K014032 · LBS
Olympus America, Inc.
Chemistry · 64d
Cleared Feb 08, 2002
OLYMPUS HDL CHOLESTEROL REAGENT
K014015 · LBS
Olympus America, Inc.
Chemistry · 65d
Cleared Feb 04, 2002
pHoenix ISE Reagents FOR Olympus AU Chemistry Systems
K020148 · CGZ
Phoenix Diagnostics, Inc.
Chemistry · 19d
Cleared Feb 01, 2002
PHOENIX ELETROLYTE CALIBRATION SET FOR THE ROCHE COBAS ISE MODULE
K020129 · JIX
Phoenix Diagnostics, Inc.
Chemistry · 18d