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FDA 510(k) Application Details - K150502
Device Classification Name
Enzyme Immunoassay, Opiates
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510(K) Number
K150502
Device Name
Enzyme Immunoassay, Opiates
Applicant
Microgenics Corporation
46500 Kato Road
Fremont, CA 94538 US
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Contact
Tammy Wharton
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Regulation Number
862.3650
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Classification Product Code
DJG
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Date Received
02/26/2015
Decision Date
10/09/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
TX - Clinical Toxicology
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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