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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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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