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FDA 510(k) Application Details - K994093
Device Classification Name
Radioimmunoassay, Phencyclidine
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510(K) Number
K994093
Device Name
Radioimmunoassay, Phencyclidine
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
000.0000
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Classification Product Code
LCL
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More FDA Info for this Product Code
Date Received
12/03/1999
Decision Date
12/16/1999
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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