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FDA 510(k) Application Details - K182280
Device Classification Name
Enzyme Immunoassay, Opiates
More FDA Info for this Device
510(K) Number
K182280
Device Name
Enzyme Immunoassay, Opiates
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
862.3650
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Classification Product Code
DJG
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More FDA Info for this Product Code
Date Received
08/22/2018
Decision Date
12/10/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
TX - Clinical Toxicology
Review Advisory Committee
TX - Clinical Toxicology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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