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FDA 510(k) Application Details - K993165
Device Classification Name
Enzyme Immunoassay, Opiates
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510(K) Number
K993165
Device Name
Enzyme Immunoassay, Opiates
Applicant
PHAMATECH
9265 ACTIVITY RD., #112-113
SAN DIEGO, CA 92126 US
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Contact
CARL A MONGIOVI
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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
09/22/1999
Decision Date
10/20/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
TX - Clinical Toxicology
Review Advisory Committee
TX - Clinical Toxicology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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