Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Chemistry ×
13,257 results
1249–1272 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
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
Cleared Sep 19, 2012
GENESIS HEALTH TECHNOLOGIES BLOOD GLUCOSE MONITORING SYSTEM
K121224 · LFR
Taidoc Technology Corporation
Chemistry · 152d