ARK METHOTREXATE ASSAY, ARK METHOTREXATE CALIBRATOR, ARK METHOTREXATE CONTROL, ARK METHOTREXATE CONTROL (CALIBRATION RAN— 510(k) K111904

Name: FDA 510(k) clearance K111904
Creator: U.S. Food and Drug Administration
Published: 2011-10-18

Substantially Equivalent

Ark Diagnostics, Inc.

FDA 510(k) clearance K111904 for ARK METHOTREXATE ASSAY, ARK METHOTREXATE CALIBRATOR, ARK METHOTREXATE CONTROL, ARK METHOTREXATE CONTROL (CALIBRATION RAN, Substantially Equivalent on 2011-10-18. Applicant: Ark Diagnostics, Inc.. Device class: Unclassified.

Clearance details

Applicant: Ark Diagnostics, Inc.
Product code: Code LAO
Device class: Unclassified
Advisory panel: Unknown
Date received: 2011-07-05
Decision date: 2011-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

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