Cleared Traditional

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

K111904 · ARK Diagnostics, Inc. · Toxicology

Oct 2011

Decision

105d

Days

—

Risk

About This 510(k) Submission

K111904 is an FDA 510(k) clearance for the ARK METHOTREXATE ASSAY, ARK METHOTREXATE CALIBRATOR, ARK METHOTREXATE CONTROL, ARK METHOTREXATE CONTROL (CALIBRATION RAN, a Enzyme Immunoassay, Methotrexate, submitted by ARK Diagnostics, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on October 18, 2011, 105 days after receiving the submission on July 5, 2011. This device falls under the Toxicology review panel.

Submission Details

510(k) Number	K111904 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 05, 2011
Decision Date	October 18, 2011
Days to Decision	105 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Summary PDF