FDA 510(k) Application Details - K882228

Device Classification Name Radioimmunoassay, Amphetamine

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510(K) Number K882228
Device Name Radioimmunoassay, Amphetamine
Applicant DIAGNOSTIC PRODUCTS CORP.
5700 WEST 96TH ST.
LOS ANGELES, CA US
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Contact KENNETH B ASARCH
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Regulation Number 862.3100

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Classification Product Code DJP
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Date Received 05/19/1988
Decision Date 08/08/1988
Decision SE - Substantially Equivalent
Classification Advisory Committee TX - Clinical Toxicology
Review Advisory Committee TX - Clinical Toxicology
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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