ARK METHOTREXATE ASSAY, ARK METHOTREXATE CALIBRATOR, ARK METHOTREXATE CONTROL, ARK METHOTREXATE CONTROL (CALIBRATION RAN


Device Classification Name

enzyme immunoassay, methotrexate

510(k) Number K111904
Device Name ARK METHOTREXATE ASSAY, ARK METHOTREXATE CALIBRATOR, ARK METHOTREXATE CONTROL, ARK METHOTREXATE CONTROL (CALIBRATION RAN
Applicant
ARK DIAGNOSTICS,INC
1190 bordeaux drive
sunnyvale, 
CA 
94089

Applicant Contact kenneth c kasper
Correspondent
ARK DIAGNOSTICS,INC
1190 bordeaux drive
sunnyvale, 
CA 
94089

Correspodent Contact kenneth c kasper
Classification Product Code
LAO  
Subsequent Product Codes
DLJ   LAS  
Date Received 07/05/2011
Decision Date 10/18/2011
Decision

substantially equivalent

(SESE)

510k Review Panel

Toxicology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No