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
985–1008 of 13,234
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Apr 10, 2014
ST AIA-PACK C-PEPTIDE II CALIBRATOR SET
K140648 · JIT
Tosoh Bioscience, Inc.
Chemistry · 28d
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