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
1009–1032 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Apr 10, 2014
ELEMENT TM LITE BLOOD GLUCOSE MONITORING SYSTEM
K133045 · NBW
Infopia Co, Ltd.
Chemistry · 195d
Cleared Apr 08, 2014
WUNDER PREGNANCY TEST
K130456 · JHI
James Nguyen
Chemistry · 410d
Cleared Apr 04, 2014
A1C GEAR SYSTEM
K130014 · LCP
Sakae Corporation
Chemistry · 457d
Cleared Apr 01, 2014
IMMULITE 2000: C-PEPTIDE CALIBRATION VERIFICATION MATERIAL, SHBG CALIBRATION...
K140541 · JJX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 28d
Cleared Mar 31, 2014
ADVIA CENTAUR VITAMIN B12 MASTER CURVE MATERIAL, TOTAL HCG MASTER CURVE...
K140505 · JJX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 32d
Cleared Mar 28, 2014
MINICAP HB A1C, MINICAP FLEX-PIERCING, HB A1C CAPILLARYS CONTROLS, HBA1C...
K133344 · LCP
Sebia
Chemistry · 149d
Cleared Mar 27, 2014
ELECSYS PRECICONTROL TS
K140534 · JJX
Roche Diagnostics
Chemistry · 23d
Cleared Mar 27, 2014
PATHFAST CTNL CALIBRATORS
K130603 · JIT
Mitsubishi Chemical Medience Corporation
Chemistry · 385d
Cleared Mar 25, 2014
RANDOX AMMONIA ETHANOL CONTROL LEVELS 1, 2 AND LEVEL 3
K140393 · JJY
Randox Laboratories Limited
Chemistry · 39d
Cleared Mar 25, 2014
NOVA STAT PROFILE PRIME CCS ANALYZER SYSTEM
K131703 · CHL
Nova Biomedical Corporation
Chemistry · 287d
Cleared Mar 21, 2014
AFINION LIPID PANEL AND AFINION LIPID PANEL CONTROL
K132031 · CHH
Axis-Shield Poc AS
Chemistry · 246d
Cleared Mar 14, 2014
DIAZYME 25-OH VITAMIN D ASSAY
K133410 · MRG
Diazyme Laboratories
Chemistry · 127d
Cleared Mar 14, 2014
FREND TSH (REAGENT CARTRIDGE)
K131928 · JLW
Nanoentek USA, Inc.
Chemistry · 260d
Cleared Mar 11, 2014
S TEST REAGENT CARTRIDGE CARBON DIOXIDE (CO2)
K140248 · KHS
Hitachi Chemical Diagnostics, Inc.
Chemistry · 40d
Cleared Mar 10, 2014
ADVIA CENTAUR TNI-ULTRA MASTER CURVE MATERIAL (MCM), ADVIA CENTAUR DIGOXIN...
K140267 · JJX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 35d
Cleared Mar 06, 2014
AUTOSURE HT BLOOD GLUCOSE MONITORING SYSTEM
K131750 · CGA
Apex BioTechnology Corp.
Chemistry · 265d
Cleared Mar 05, 2014
IMMULITE 2000 DHEA-SO4
K140258 · JJX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 30d
Cleared Feb 28, 2014
CERA-CHEK 1070 BLOOD GLUCOSE MONITORING SYSTEM
K131727 · LFR
Ceragem Medisys, Inc.
Chemistry · 261d
Cleared Feb 28, 2014
HEMOGLOBIN A1C, HEMOGLOBIN A1C CALIBRATORS, HEMOGLOBIN A1C CONTROLS
K130255 · PDJ
Abbott Laboratories
Chemistry · 392d
Cleared Feb 27, 2014
EMV3.1 PRO BLOOD GLUCOSE SYSTEM AND EMV3.1 SELF MONITORING BLOOD GLUCOSE SYSTEM
K133647 · NBW
Eps Bio Technology Corp.
Chemistry · 92d
Cleared Feb 25, 2014
WONDFO MULTI-DRUG URINE TEST CUP, PANEL
K133968 · DKZ
Guangzhou Wondfo Biotech Co., Ltd.
Chemistry · 61d
Cleared Feb 21, 2014
EASY PLUS II BLOOD GLUCOSE MONITORING SYSTEM,EASY PLUS II MULTI BLOOD GLUCOSE...
K133509 · NBW
Biotest Medical Corp.
Chemistry · 99d
Cleared Feb 21, 2014
ADVIA CENTAUR TESTOSTERONE (TSTO)
K133491 · CDZ
Siemens Healthcare Diagnostics, Inc.
Chemistry · 100d
Cleared Feb 05, 2014
ADVIA CENTAUR INTACT PARATHYROID HORMONE (IPTH) ASSAY
K133601 · CEW
Siemens Healthcare Diagnostics, Inc.
Chemistry · 72d