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
1561–1584 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Feb 14, 2011
DIMENSION VISA HBA1C, MODEL K3105A
K102045 · LCP
Siemens Heatlhcare Diagnostics, Inc.
Chemistry · 208d
Cleared Feb 11, 2011
ROCHE ORAL FLUID COCAINE
K101160 · DIO
Roche Diagnostics
Chemistry · 291d
Cleared Feb 11, 2011
THERMO SCIENTIFIC QMS EVEROLIMUS REAGENTS, CALIBRATORS AND CONTROLS
K100144 · OUF
Microgenics Corp.
Chemistry · 388d
Cleared Feb 11, 2011
ROCHE ORAL FLUID OPIATES, DAT QUAL CAL A, DAT CONTROL SET A AND DAT SQ CAL A
K093867 · DJG
Roche Diagnostics
Chemistry · 402d
Cleared Feb 11, 2011
ONE TOUCH VERIO BLOOD GLUCOSE MONITORING SYSTEM
K093745 · NBW
Lifescan, Inc.
Chemistry · 434d
Cleared Feb 10, 2011
LIFESCAN ONETOUCH SELECT / ULTRA / VITA GLUCOSE CONTROL SOLUTION
K103553 · JJX
Bionostics, Inc.
Chemistry · 69d
Cleared Feb 08, 2011
I-STAT 1 WIRELESS ANALYZER
K103195 · CGA
Abbott Point of Care, Inc.
Chemistry · 102d
Cleared Feb 04, 2011
MULTICONSTITUENT CALIBRATOR
K103403 · JIX
Abbott Laboratories
Chemistry · 77d
Cleared Feb 04, 2011
URITEK TC-101 URINE ANALYZER, URINE REAGENT STRIPS 10, MODELS TC-101, URS-10
K101673 · JIL
Teco Diagnostics
Chemistry · 234d
Cleared Feb 04, 2011
NEOPAC SOFTWARE, 3007 DIGITAL PHOTOMETER/FLUOROMETER MODEL NA, 307 AND 350D
K101392 · KQP
Astoria-Pacific, Inc.
Chemistry · 262d
Cleared Feb 02, 2011
MISSION LIQUID URINE CONTROL, MISSION LIQUID DIPTUBE URINE CONTROL, MISSION...
K103387 · JJW
ACON Laboratories, Inc.
Chemistry · 76d
Cleared Jan 25, 2011
DIMENSION VISA ENZ 2 CAL
K103612 · JIX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 47d
Cleared Jan 25, 2011
FDI GLUCOSE CONTROL SOLUTION FOR FREESTYLE
K103450 · JJX
Fujirebio Diagnostics,Inc.
Chemistry · 62d
Cleared Jan 25, 2011
MSC LIPID CONTROL
K103271 · JJY
Maine Standards Co.
Chemistry · 81d
Cleared Jan 25, 2011
DIATRON PICTUS 400
K101741 · CGA
Diatron Group
Chemistry · 217d
Cleared Jan 25, 2011
ORAL FLUID PHENCYCLIDINE
K093989 · LCM
Roche Diagnostics
Chemistry · 397d
Cleared Jan 20, 2011
TQ HBA1C GEN3
K102914 · LCP
Roche
Chemistry · 111d
Cleared Jan 20, 2011
ELECYSYS SHBG
K102814 · CDZ
Roche Diagnostics
Chemistry · 114d
Cleared Jan 14, 2011
PROLYTE ELECTROLYTE ANALYZER
K102959 · JGS
Diamond Diagnostics, Inc.
Chemistry · 101d
Cleared Jan 14, 2011
DIAZYME 25-HYDROXY VITAMIN D ASSAY KIT MODEL DZ688A, DIAZYME 25-HYDROXY...
K102432 · MRG
Diazyme Laboratories
Chemistry · 141d
Cleared Jan 14, 2011
AUDIT MICROCV PROTEIN LINEARITY SET
K101216 · JJY
Aalto Scientific, Ltd.
Chemistry · 259d
Cleared Jan 14, 2011
EASYRA SODIUM ASSAY, EASYRA POTASSIUM ASSAY, EASYRA CHLORIDE ASSAY, EASYRA...
K100829 · JGS
Medica Corp.
Chemistry · 296d
Cleared Jan 10, 2011
AUDIT MICROCV CARDIAC MARKERS LINEARITY SET
K102617 · JJY
Aalto Scientific, Ltd.
Chemistry · 122d
Cleared Jan 07, 2011
ELECSYS DHEA-S CALCHECK 5
K103402 · JJX
Roche Diagnostics
Chemistry · 49d