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
1321–1344 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared May 10, 2012
ELECSYS LH CALCHECK 5
K121279 · JJX
Roche Diagnostics
Chemistry · 10d
Cleared May 10, 2012
HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE GLUCOSE (GLU)
K120369 · CFR
Hitachi Chemical Diagnostics, Inc.
Chemistry · 94d
Cleared May 10, 2012
COMPLETE D 25-OH VITAMIN D CONTROL
K113177 · JJX
Quantimetrix Corp.
Chemistry · 195d
Cleared May 09, 2012
LOCI CARDIAC TROPONIN-I CONTROL (LOW), LCTNI CON L
K121084 · JJX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 29d
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