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
913–936 of 13,234
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Nov 19, 2014
PANTEX SALIVARY DIRECT TESTOSTERONE EIA KIT, Pantex Sample Collection Device
K133303 · JKA
Bio-Analysis, Inc.
Chemistry · 390d
Cleared Nov 17, 2014
CLINITEK NOVUS
K140717 · KQO
Siemens Healthcare Diagnostics
Chemistry · 242d
Cleared Nov 13, 2014
DRAEGER JAUNDICE METER JM-105
K133175 · MQM
Draeger Medical Systems, Inc.
Chemistry · 392d
Cleared Nov 13, 2014
ABL90 FLEX
K132691 · MQM
Radiometer Medical Aps
Chemistry · 442d
Cleared Nov 06, 2014
NIOX VERO AIRWAY INFLAMMATION MONITOR
K133898 · MXA
Aerocrine AB
Chemistry · 321d
Cleared Oct 30, 2014
IMMULITE 2000 Beta-2 Microglobulin Calibration Verification Material,...
K142878 · JJX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 28d
Cleared Oct 29, 2014
ADVIA Centaur C-peptide (CpS) Master Curve Material (MCM), ADVIA Centaur...
K142864 · JJX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 28d
Cleared Oct 29, 2014
IMMULITE 2000 LH Calibration Verification Material (CVM), IMMULITE 2000 Free...
K142811 · JJX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 30d
Cleared Oct 22, 2014
VANTERA CLINICAL ANALYZER
K133849 · NSU
Liposcience
Chemistry · 307d
Cleared Oct 17, 2014
Stat Profile Prime ABG Analyzer System (incl. Controls, Calibrators)
K142220 · CHL
Nova Biomedical Corporation
Chemistry · 66d
Cleared Oct 17, 2014
ELECSYS FOLATE III
K141426 · CGN
Roche Diagnostics
Chemistry · 140d
Cleared Oct 16, 2014
Healgen Oxazepam Test (Strip, Cassette, Cup, Dip Card), Healgen Morphine Test...
K142280 · DJG
Healgen Scientific, LLC
Chemistry · 62d
Cleared Oct 15, 2014
Urine/CSF Albumin, Urine/CSF Albumin Calibrator
K142346 · DCF
Beckman Coulter Ireland, Inc.
Chemistry · 54d
Cleared Oct 02, 2014
BioScanner Plus Glucose Test System, PTS PANELS Chol+Glu Test Panel System,...
K142302 · CGA
Polymer Technology Systems, Inc.
Chemistry · 45d
Cleared Sep 30, 2014
FREESTYLE PRECISION NEO BLOOD GLUCOSE: MONITORING SYSTEM, TEST STRIPS (50CT),...
K140371 · NBW
Abbott Diabetes Care, Inc.
Chemistry · 228d
Cleared Sep 24, 2014
GLUCOVITAAL H1A BLOOD GLUCOSE MONITORING SYSTEM
K141829 · NBW
Ceragem Medisys, Inc.
Chemistry · 79d
Cleared Sep 24, 2014
STATSTRIP GLUCOSE HOSPITAL METER SYSTEM
K132121 · PZI
Nova Biomedical Corporation
Chemistry · 441d
Cleared Sep 18, 2014
RANDOX ALDOLASE CALIBRATION SERUM
K142181 · JIT
Randox Laboratories Limited
Chemistry · 41d
Cleared Sep 18, 2014
FIA Blood Glucose Monitoring System (G2)
K131173 · NBW
Hmd Biomedical, Inc.
Chemistry · 511d
Cleared Sep 17, 2014
GLUCOCARD 01 Blood Glocose Monitoring System/ReliOn Confirm Blood Glucose...
K142336 · CGA
Arkray Factory, Inc.
Chemistry · 27d
Cleared Sep 16, 2014
Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access...
K140496 · CDD
Beckman Coulter, Inc.
Chemistry · 201d
Cleared Sep 08, 2014
IN TOUCH BLOOD GLUCOSE MONITORING SYSTEM
K133584 · CGA
Eoshealth, Inc.
Chemistry · 291d
Cleared Sep 05, 2014
ELECSYS ESTRADIOL III CALCHECK 5
K142127 · JJX
Roche Diagnostics
Chemistry · 32d
Cleared Sep 05, 2014
GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, RELION MICRO BLOOD GLUCOSE...
K142035 · NBW
Arkray Factory, Inc.
Chemistry · 39d