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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,234 results
1225–1248 of 13,234
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Nov 30, 2012
GENSTRIP TEST STRIP MODEL 100-201
K103542 · NBW
Shasta Technologies, LLC
Chemistry · 729d
Cleared Nov 29, 2012
COBAS C TINA-QUANT LIPOPROTEIN (A) GEN 2 ASSAY MODEL 05852625190
K122722 · DFC
Roche Diagnostics
Chemistry · 85d
Cleared Nov 28, 2012
DIAZYME 25-HYDROXY VITAMIN D EIA KIT DIAZYME 25-HYDROXY VITAMIN D EIA CONTROL...
K122420 · MRG
Diazyme Laboratories
Chemistry · 111d
Cleared Nov 27, 2012
ABBOTT ARCHITECT FREE T4
K123379 · CEC
Abbott Laboratories
Chemistry · 26d
Cleared Nov 21, 2012
ACON ON CALL VIVID PAL BLOOD GLUCOSE MONITORING SYSTEM
K122110 · CGA
ACON Laboratories, Inc.
Chemistry · 127d
Cleared Nov 21, 2012
AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS 1-3, AQT90 FLEX...
K120326 · JHX
Radiometer Medical Aps
Chemistry · 293d
Cleared Nov 20, 2012
LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 1 MODEL 271, LIQUICHEK...
K123198 · JJY
Bio-Rad Laboratories
Chemistry · 40d
Cleared Nov 20, 2012
RANDOX IMMUNOASSAY SPECIALITY CONTROL (II), LEVEL 1, LEVEL 2 AND LEVEL 3
K121603 · JJY
Randox Laboratories, Ltd.
Chemistry · 228d
Cleared Nov 16, 2012
ABL90 FLEX
K122729 · CHL
Radiometer Medical Aps
Chemistry · 71d
Cleared Nov 09, 2012
PRECICHEK NS-101 POCT PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM
K113314 · LFR
Hmd Biomedical, Inc.
Chemistry · 366d
Cleared Oct 26, 2012
ABL90 FLEX
K122642 · CHL
Radiometer Medical Aps
Chemistry · 58d
Cleared Oct 26, 2012
VARIANT II TURBO HBA1C KIT-2.0 VARIANT II TURBO HEMOGLOBIN TESTING SYSTEM
K122472 · LCP
Bio-Rad Laboratories, Inc., Clinical...
Chemistry · 73d
Cleared Oct 24, 2012
VITROS CHEMISTRY PRODUCTS ECO2 SLIDES
K120765 · KHS
Ortho-Clinical Diagnostics, Inc.
Chemistry · 225d
Cleared Oct 17, 2012
LIQUICKEK IMMUNOASSAY PLUS CONTROL, LEVEL 1 MODEL 267, LIQUICHEK IMMUNOASSAY...
K122838 · JJY
Bio-Rad Laboratories
Chemistry · 30d
Cleared Oct 12, 2012
RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORS
K122398 · JIX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 66d
Cleared Oct 12, 2012
GLYCOSYLATED HEMOGLOBIN ASSAY
K120199 · LCP
Beckman Coulter, Inc.
Chemistry · 263d
Cleared Oct 11, 2012
ACCU-CHEK INFORM II BLOOD GLUCOSE MONITORING SYSTEM
K121679 · NBW
Roche Diagnostics
Chemistry · 126d
Cleared Oct 05, 2012
ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE...
K122757 · CHH
Alfa Wassermann Diagnostic...
Chemistry · 28d
Cleared Oct 05, 2012
EPOC CHLORIDE TEST AND EPOC CREATININE TEST
K113726 · CGL
Epocal, Inc.
Chemistry · 291d
Cleared Oct 03, 2012
ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH...
K122858 · JFJ
Elitechgroup
Chemistry · 15d
Cleared Oct 03, 2012
ADVIA CHEMISTRY MYOGLOBIN REAGENT, ADVIA CHEMISTRY MYOGLBIN CALIBRATOR
K122599 · DDR
Siemens Healthcare Diagnostics, Inc.
Chemistry · 37d
Cleared Sep 24, 2012
QUIKRESPONSE ONE STEP MIDSTREAM EARLY PREGRANCY TEST
K112449 · LCX
Tianjin New Bay Bioresearch Co., Ltd.
Chemistry · 396d
Cleared Sep 21, 2012
DIAZYME HSCRP POC TEST KIT
K121558 · DCK
Diazyme Laboratories
Chemistry · 115d
Cleared Sep 20, 2012
RANDOX MATERNAL CONTROL, LEVELS 1, 2 AND 3
K113720 · JJY
Randox Laboratories, Ltd.
Chemistry · 276d