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FDA 510(k) Application Details - K000447
Device Classification Name
Gas Chromatography, Methamphetamine
More FDA Info for this Device
510(K) Number
K000447
Device Name
Gas Chromatography, Methamphetamine
Applicant
PHAMATECH
9265 ACTIVITY RD., #112-113
SAN DIEGO, CA 92126 US
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Contact
CARL A MONGIOVI
Other 510(k) Applications for this Contact
Regulation Number
862.3610
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Classification Product Code
LAF
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More FDA Info for this Product Code
Date Received
02/10/2000
Decision Date
03/07/2000
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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