FDA 510(k) Application Details - K992634

Device Classification Name Gas Chromatography, Methamphetamine

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510(K) Number K992634
Device Name Gas Chromatography, Methamphetamine
Applicant DIAGNOSTIC PRODUCTS CORP.
5700 WEST 96TH ST.
LOS ANGELES, CA 90045-5597 US
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Contact EDWARD M LEVINE
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Regulation Number 862.3610

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Classification Product Code LAF
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Date Received 08/06/1999
Decision Date 01/20/2000
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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