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
1585–1608 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
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
Cleared Jan 07, 2011
ON CALL PLUS DIABETES MONITORING SOFTWARE
K101371 · NBW
ACON Laboratories, Inc.
Chemistry · 235d
Cleared Jan 07, 2011
OPTI CCA-TS, B-LAC CASSETTE MODEL BP7561
K093280 · CHL
Opti Medical Systems, Inc.
Chemistry · 444d
Cleared Jan 03, 2011
PLAC TEST REAGENT KIT, MODELS 90107, 90112, 90115, 90116, 10-0112, 10-0113,...
K101853 · NOE
Diadexus, Inc.
Chemistry · 186d
Cleared Dec 28, 2010
LZI AMPHETAMINES 500 HOMOGENOUS ENZYME IMMUNOASSAY
K102210 · DKZ
Lin-Zhi International, Inc.
Chemistry · 145d