FDA 510(k) Application Details - K970724

Device Classification Name Enzyme Immunoassay, Amphetamine

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510(K) Number K970724
Device Name Enzyme Immunoassay, Amphetamine
Applicant DRIAL CONSULTANTS, INC.
1420 LOS ANGELES AVE. STE 201
SIMI VALLEY, CA 93065 US
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Contact CLEVE W LAIRD
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Regulation Number 862.3100

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Classification Product Code DKZ
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Date Received 02/27/1997
Decision Date 05/13/1997
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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