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
937–960 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
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
Not Cleared Sep 05, 2014
NEPHROCHECK TEST SYSTEM
DEN130031 · PIG
Astute Medical, Inc.
Chemistry · 457d