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FDA 510(k) Application Details - K021526
Device Classification Name
Radioimmunoassay, Tricyclic Antidepressant Drugs
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510(K) Number
K021526
Device Name
Radioimmunoassay, Tricyclic Antidepressant Drugs
Applicant
ACON LABORATORIES, INC.
4108 SORRENTO VALLEY BLVD.
SAN DIEGO, CA 92121 US
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Contact
EDWARD TUNG
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Regulation Number
862.3910
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Classification Product Code
LFG
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More FDA Info for this Product Code
Date Received
05/10/2002
Decision Date
07/17/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
TX - Clinical Toxicology
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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