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
2017–2040 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
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
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