FDA 510(k) Application Details - K022693

Device Classification Name Thin Layer Chroomatography, Tricyclic Antidepressant Drugs

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510(K) Number K022693
Device Name Thin Layer Chroomatography, Tricyclic Antidepressant Drugs
Applicant ALFA SCIENTIFIC DESIGNS, INC.
12330 STOWE DR.
POWAY, CA 92064 US
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Contact NAISHU WANG
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Regulation Number 862.3910

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Classification Product Code MLK
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Date Received 08/13/2002
Decision Date 12/09/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee TX - Clinical Toxicology
Review Advisory Committee TX - Clinical Toxicology
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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