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
1345–1368 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared May 08, 2012
RANDOX COCAINE METABOLITE
K113751 · DIO
Randox Laboratories, Ltd.
Chemistry · 139d
Cleared May 08, 2012
ELEMENT BLOOD GLUCOSE MONITORING SYSTEM
K113670 · CGA
Infopia Co, Ltd.
Chemistry · 147d
Cleared May 08, 2012
CALCIUM GEN. 2
K113521 · CHW
Roche Diagnostics
Chemistry · 161d
Cleared May 08, 2012
PANTEX AM/PM SALIVARY CORTISOL ENZYME IMMUNOASSAY
K102841 · NHG
Pantex, Div. Bio-Analysis, Inc.
Chemistry · 587d
Cleared May 07, 2012
AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON
K112790 · LPS
Axis-Shield Diagnostics, Ltd.
Chemistry · 224d
Cleared May 03, 2012
CARESENS N POP BLOOD GLUCOSE MONITORING SYSTEM CARESENS N POP BLOOD GLUCOSE...
K120351 · NBW
I-Sens, Inc.
Chemistry · 87d
Cleared May 03, 2012
RAPIDPOINT 500 BLOOD GAS ANALYER
K113216 · KHP
Siemens Healthcare Diagnostics
Chemistry · 184d
Cleared May 03, 2012
GEM PREMIER 4000
K112995 · CEM
Instrumentation Laboratory CO
Chemistry · 209d
Cleared May 01, 2012
PSYCHEMEDICS PHENCYCLIDINE EIA
K111928 · LCM
Psychemedics Corp.
Chemistry · 300d
Cleared May 01, 2012
PSYCHEMEDICS METHAMPHETAMINE EIA
K111927 · LAF
Psychemedics Corp.
Chemistry · 300d
Cleared Apr 30, 2012
ABX PENTRA CREATININE 120 CP
K110530 · CGX
HORIBA ABX SAS
Chemistry · 431d
Cleared Apr 24, 2012
PICCOLO TRGLYCERIDES-CAPILLARY TEST SYSTEM
K120664 · JGY
Abaxis, Inc.
Chemistry · 50d
Cleared Apr 24, 2012
PICCOLO HDL-CAPILLARY TEST SYSTEM
K120662 · JHM
Abaxis, Inc.
Chemistry · 50d
Cleared Apr 24, 2012
AP-3000 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL SOLUTION
K103230 · CGA
Bestgen Biotech Corp.
Chemistry · 540d
Cleared Apr 23, 2012
HOME PREGNANCY TEST
K112315 · JHI
Newscen Coast Bio-Pharmaceutical Co.,...
Chemistry · 256d
Cleared Apr 17, 2012
DIAMOND TOKYO BOEKI ISE MODULE CALIBRATOR 1,2,1-2
K120591 · JIT
Diamond Diagnostics, Inc.
Chemistry · 49d
Cleared Apr 17, 2012
HEALGEN 11 REAGENT STRIP FOR URINALYSIS, HEALGEN 10 REAGENT STRIP FOR...
K111999 · JIO
Healgen Scientific, LLC
Chemistry · 279d
Cleared Apr 17, 2012
IND URINARY TRACT INFECTION (UTI) TEST STRIPS
K103037 · NGJ
Ind Diagnostic, Inc.
Chemistry · 551d
Cleared Apr 12, 2012
U-RIGHT TD-4280 BLOOD GLUCOSE MONITORING SYSTEM
K113768 · LFR
Taidoc Technology Corporation
Chemistry · 113d
Cleared Apr 09, 2012
ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEMS
K112653 · JJX
ACON Laboratories, Inc.
Chemistry · 210d
Cleared Apr 06, 2012
MEG-2B BLOOD GLUCOSE MONITORING SYSTEM, PRO BLOOD GLUCOSE MONITORING SYSTEM,...
K120448 · CGA
Apex BioTechnology Corp.
Chemistry · 52d
Cleared Mar 30, 2012
DIAZYME CYSTATIN C POC TEST KIT
K111664 · NDY
Diazyme Laboratories
Chemistry · 290d
Cleared Mar 29, 2012
FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEM
K120568 · NBW
Abbott Diabetes Care, Inc.
Chemistry · 31d
Cleared Mar 29, 2012
ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE...
K112538 · CHH
Alfa Wassermann Diagnostic...
Chemistry · 210d