510(k) K111904

Device

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

Applicant

ARK DIAGNOSTICS,INC

510(k) number

K111904

Product code

LAO  

Decision

Substantially Equivalent (SESE)

Decision date

2011-10-18

Date received

2011-07-05

Regulation

510(k) Premarket Notification

Classification name

Enzyme Immunoassay, Methotrexate

Medical specialty

510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices

Review panel

Toxicology

Device class

U

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

No