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
2137–2160 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Apr 23, 2007
DIAZYME CREATININE LIQUID REAGENTS ASSAY
K062105 · JFY
Diazyme Laboratories
Chemistry · 273d
Cleared Apr 18, 2007
SMS MULTI GLUCOSE CONTROL, MODEL 2120049
K070506 · JJX
Medical Specialties Supply Co., Inc.
Chemistry · 56d
Cleared Apr 17, 2007
ACE HEMOGLOBIN A1C REAGENT, MODEL ACI-21, HEMOGLOBIN A1C CALIBRATORS, MODEL...
K063306 · LCP
Alfa Wassermann, Inc.
Chemistry · 167d
Cleared Apr 13, 2007
MULTI-ANALYTE CHEMISTRY CALIBRATOR
K070207 · JIX
Pointe Scientific, Inc.,
Chemistry · 81d
Cleared Apr 12, 2007
SMS GLUCOSE CONTROL, MODEL 2120061
K070649 · JJX
Spectrum Medical Supply, Inc.
Chemistry · 35d
Cleared Apr 11, 2007
AMMONIA/ALCOHOL CONTROL SET
K070504 · JJY
Pointe Scientific, Inc.,
Chemistry · 49d
Cleared Apr 11, 2007
TECO HOMOCYSTEINE ENZYMATIC ASSAY
K063701 · LPS
Teco Diagnostics
Chemistry · 119d
Cleared Apr 10, 2007
FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM
K070850 · NBW
Abbott Diabetes Care, Inc.
Chemistry · 13d
Cleared Apr 09, 2007
MODIFICATION TO: DIRECT ENZYMATIC HBA1C ASSAY KIT, MODEL# DZ168A, DZ168A-CAL,...
K070734 · LCP
Diazyme Laboratories
Chemistry · 24d
Cleared Apr 09, 2007
ADVOCATE DUO BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM, MODEL TD-3223
K070641 · NBW
Taidoc Technology Corporation
Chemistry · 32d
Cleared Apr 09, 2007
VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B-HCG II REAGENT PACK, CALIBRATORS,...
K063720 · DHA
Ortho-Clinical Diagnostics
Chemistry · 115d
Cleared Apr 06, 2007
OLYMPUS URIC ACID REAGENT, MODEL OSR6X98
K062862 · KNK
Olympus America, Inc.
Chemistry · 193d
Cleared Apr 06, 2007
COMBI SCAN100
K061846 · JIL
Analyticon Biotechnologies AG
Chemistry · 284d
Cleared Apr 06, 2007
COMBI SCAN 500 URINE TEST STRIP ANALYZER, MODEL A93005
K061812 · JIL
Analyticon Biotechnologies AG
Chemistry · 284d
Cleared Apr 02, 2007
LYPHOCHEK DIABETES CONTROL
K070546 · GGM
Bio-Rad Laboratories
Chemistry · 35d
Cleared Mar 30, 2007
CISBIO RENIN RIA TEST
K062120 · CIB
Cis Bio International
Chemistry · 248d
Cleared Mar 28, 2007
APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS
K061377 · MSJ
Pointe Scientific, Inc.,
Chemistry · 315d
Cleared Mar 23, 2007
OLYMPUS TRIGLYCERIDE TEST SYSTEM
K063804 · CDT
Olympus America, Inc.
Chemistry · 91d
Cleared Mar 23, 2007
THERMO ELECTRON ENZYMATIC CREATININE, MODEL TR35401
K061412 · JFY
Thermo-Electron Corp.
Chemistry · 305d
Cleared Mar 21, 2007
DIMENSION VISTA STFR FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND...
K063663 · DDG
Dade Behring, Inc.
Chemistry · 103d
Cleared Mar 21, 2007
HBA1C
K063209 · LCP
Thermo Electron OY
Chemistry · 149d
Cleared Mar 20, 2007
ELECSYS PTH TEST SYSTEM
K070391 · CEW
Roche Diagnostics Corp.
Chemistry · 39d
Cleared Mar 19, 2007
TDM CONTROL SET, MODEL CAT# 04521536
K070200 · JJY
Roche Diagnostics Corp.
Chemistry · 56d
Cleared Mar 19, 2007
DIMENSION VISTA CTNI FLEX REAGENT CARTRIDGE
K063756 · MMI
Dade Behring, Inc.
Chemistry · 90d