FDA 510(k) Application Details - K021526

Device Classification Name	Radioimmunoassay, Tricyclic Antidepressant Drugs   More FDA Info for this Device
510(K) Number	K021526
Device Name	Radioimmunoassay, Tricyclic Antidepressant Drugs
Applicant	ACON LABORATORIES, INC. 4108 SORRENTO VALLEY BLVD. SAN DIEGO, CA 92121 US Other 510(k) Applications for this Company
Contact	EDWARD TUNG Other 510(k) Applications for this Contact
Regulation Number	862.3910   More FDA Info for this Regulation Number
Classification Product Code	LFG Other 510(k) Applications for this Device   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