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
1993–2016 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Mar 19, 2008
ACTIVATED ASPARTATE AMINOTRANSFERASE
K071525 · CIT
Abbott Laboratories
Chemistry · 289d
Cleared Mar 17, 2008
AXSYM HBA1C REAGENTS, AXSYM HBA1C CALIBRATORS, AXSYM HBA1C CONTROLS
K072686 · LCP
Axis-Shield Diagnostics, Ltd.
Chemistry · 175d
Cleared Mar 14, 2008
APIERON INSIGHT EXHALED NITRIC OXIDE (ENO) SYSTEM
K073265 · MXA
Apieron, Inc.
Chemistry · 115d
Cleared Mar 13, 2008
DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT...
K073604 · CEC
Dade Behring, Inc.
Chemistry · 83d
Cleared Mar 11, 2008
DRAEGER ALCOTEST 6510
K063443 · DJZ
Drager Safety
Chemistry · 483d
Cleared Mar 07, 2008
LUMINEX LX 100/200 INSTRUMENT
K073506 · NSU
Luminex Corp.
Chemistry · 85d
Cleared Mar 07, 2008
DIAZYME APOLIPOPROTEIN B ASSAY, MODEL DZXXX-X
K073488 · MSJ
Diazyme Laboratories
Chemistry · 137d
Cleared Mar 05, 2008
PRODIGY VOICE BLOOD GLUCOSE MONITORING SYSTEM
K073118 · NBW
Diagnostic Devices, Inc.
Chemistry · 121d
Cleared Mar 05, 2008
ABX PENTRA URINE CAL
K071779 · JIX
Horiba Abx
Chemistry · 247d
Cleared Mar 03, 2008
CLEVER CHEK MODEL TD-4232 BLOOD GLUCOSE MONITORING SYSTEM
K073119 · NBW
Taidoc Technology Corporation
Chemistry · 119d
Cleared Mar 03, 2008
NIOX MINO
K072816 · MXA
Aerocrine AB
Chemistry · 153d
Cleared Feb 29, 2008
VIDAS NT-PROBNP ASSAY, MODEL: 30 449
K073091 · NBC
bioMerieux, Inc.
Chemistry · 120d
Cleared Feb 29, 2008
MAJOR III BLOOD GLUCOSE MONITORING SYSTEM
K072274 · NBW
Bestgen Biotech Corp.
Chemistry · 198d
Cleared Feb 28, 2008
CALCIUM, SCAL, NORTROL, ABTROL
K073355 · CJY
Thermofisher Scientific OY
Chemistry · 91d
Cleared Feb 28, 2008
ALKALINE PHOSPHATASE (IFCC) PLUS, ECAL, NORTROL, ABTROL
K073191 · CJE
Thermofisher Scientific OY
Chemistry · 107d
Cleared Feb 28, 2008
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM310
K072054 · NBW
Bionime Corporation
Chemistry · 217d
Cleared Feb 27, 2008
ELECSYS PROBNP II CALCHECK
K080147 · JJX
Roche Diagnostics Corp.
Chemistry · 36d
Cleared Feb 21, 2008
DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B
K073072 · JHM
Dade Behring, Inc.
Chemistry · 113d
Cleared Feb 20, 2008
EASYRA CHOLESTEROL REAGENT
K072249 · CHH
Medica Corp.
Chemistry · 191d
Cleared Feb 12, 2008
AFINION ACR AND ACR CONTROL
K072409 · JFY
Axis-Shield Poc AS
Chemistry · 169d
Cleared Feb 05, 2008
ELECSYS PROBNP II, PRECICONTROL CARDIAC II, PROBNP II CALSET
K072437 · NBC
Roche Diagnostics
Chemistry · 166d
Cleared Feb 05, 2008
PATHFAST NTPROBNP AND D-DIMER TESTS
K072189 · NBC
Mitsubishi Kagaku Iatron
Chemistry · 183d
Cleared Feb 01, 2008
DIAZYME CYSTATIN C: ASSAY KIT (DZ133A-K), CALIBRATOR (DZ133A-CAL), CONTROLS...
K072270 · NDY
Diazyme Laboratories
Chemistry · 170d
Cleared Feb 01, 2008
BS-200 CHEMISTRY ANALYZER, MODE BS-200
K072018 · CFR
Shenzhen Mindray Bio-Medical...
Chemistry · 193d