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
2017–2040 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jan 30, 2008
WAVESENSE KEYNOTE CODELESS BLOOD GLUCOSE MONITORING SYSTEM
K073573 · NBW
Agamatrix
Chemistry · 41d
Cleared Jan 29, 2008
ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY 17-A-HYDROXYPROGESTERONE
K062534 · JLX
Drg Intl., Inc.
Chemistry · 518d
Cleared Jan 24, 2008
QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945
K073080 · JJY
Bio-Rad Laboratories
Chemistry · 85d
Cleared Jan 24, 2008
CYSTATIN C KIT FOR USE ON THE SPAPLUS ANALYZER
K072166 · NDY
The Binding Site
Chemistry · 171d
Cleared Jan 22, 2008
DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS
K072523 · LBR
General Atomics
Chemistry · 137d
Cleared Jan 03, 2008
DIMENSION ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE WITH MODEL DF270
K073055 · JFY
Dade Behring, Inc.
Chemistry · 65d
Cleared Jan 03, 2008
DIAZYME HDL-CHOLESTEROL REAGENT,CALIBRATOR, CONTROLS
K072395 · LBS
Diazyme Laboratories
Chemistry · 129d
Cleared Dec 27, 2007
CHOLESTRAK HDL CHOLESTEROL HOME TEST
K072836 · LBS
Accutech, LLC
Chemistry · 85d
Cleared Dec 21, 2007
PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4227, CLEVER CHEK...
K072784 · NBW
Taidoc Technology Corporation
Chemistry · 81d
Cleared Dec 21, 2007
IRISPEC,CA/CB/CC
K072640 · JJW
Iris Diagnostics
Chemistry · 94d
Cleared Dec 20, 2007
PLAC TEST REAGENT KIT,CALIBRATOR KIT, LP-PLA2 CONTROL KIT, MODEL(S)...
K072599 · NOE
Diadexus, Inc.
Chemistry · 97d
Cleared Dec 20, 2007
ENVOY 500 HDL
K071706 · LBS
Clinical Data, Inc.
Chemistry · 182d
Cleared Dec 18, 2007
ONE STEP HCG URINE PREGNANCY TEST (STRIP), MODEL B01-S, ONE STEP HCG URINE...
K071930 · LCX
Blue Cross Bio-Medical Co., Ltd.
Chemistry · 158d
Cleared Dec 14, 2007
VIDAS TROPONIN I ULTRA (TNIU) ASSAY, MODEL 30 448
K063243 · MMI
bioMerieux, Inc.
Chemistry · 414d
Cleared Dec 12, 2007
DIMENSION VISTA SYSTEM BILIRUBIN CALIBRATOR, MODEL KC210
K072717 · JIT
Dade Behring, Inc.
Chemistry · 78d
Cleared Dec 11, 2007
LIQUICHEK MICROALBUMIN CONTROL LEVEL 1, LEVEL 2, CONTROL MINIPAK
K072835 · JJY
Bio-Rad, Diagnostics Grp.
Chemistry · 69d
Cleared Dec 11, 2007
LYPHOCHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL , ABBOTT IMMUNOSUPPRESSANT MCC
K072721 · DIF
Bio-Rad, Diagnostics Grp.
Chemistry · 76d
Cleared Dec 07, 2007
VITROS CHEMISTRY PRODUCTS K+ SLIDES AND CALIBRATOR KIT 2
K073157 · CEM
Ortho-Clinical Diagnostics, Inc.
Chemistry · 29d
Cleared Dec 07, 2007
TRIAGE TOTAL CONTROLS 5, TRIAGE TOTAL CALIBRATION VERIFICATION 5
K072892 · JJY
Biosite Incorporated
Chemistry · 58d
Cleared Dec 07, 2007
ADVIA CHEMISTRY TOTAL BILIRUBIN_2
K063845 · JFM
Bayer Healthcare, LLC
Chemistry · 345d
Cleared Dec 06, 2007
FASTPACK HCG IMMUNOASSAY
K072264 · JHI
Qualigen, Inc.
Chemistry · 113d
Cleared Dec 04, 2007
MICROPROTEIN REAGENT SET
K070757 · JGP
Pointe Scientific, Inc.,
Chemistry · 259d
Cleared Dec 03, 2007
CREATININE (ENZYMATIC)
K070824 · JFY
Thermofisher Scientific OY
Chemistry · 252d
Cleared Dec 03, 2007
EASYPLUS MINI SELF MONITORING GLUCOSE TEST SYSTEM, MODELS R1 AND R2
K070053 · NBW
Eps Bio Technology Corp.
Chemistry · 333d