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FDA 510(k) Application Details - K150606
Device Classification Name
Enzyme Immunoassay, Opiates
More FDA Info for this Device
510(K) Number
K150606
Device Name
Enzyme Immunoassay, Opiates
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
P.O. BOX 6101, M/S 514
NEWARK, DE 19714-6101 US
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Contact
FRANCES A. DILLON
Other 510(k) Applications for this Contact
Regulation Number
862.3650
More FDA Info for this Regulation Number
Classification Product Code
DJG
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More FDA Info for this Product Code
Date Received
03/10/2015
Decision Date
10/23/2015
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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