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FDA 510(k) Application Details - K163359
Device Classification Name
Enzyme Immunoassay, Methotrexate
More FDA Info for this Device
510(K) Number
K163359
Device Name
Enzyme Immunoassay, Methotrexate
Applicant
ARK Diagnostics, Inc.
48089 Fremont Boulevard
Fremont, CA 94538 US
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Contact
Cherry Mun
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
LAO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/30/2016
Decision Date
08/18/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
TX - Clinical Toxicology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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