FDA 510(k) Application Details - K041946

Device Classification Name	Radioimmunoassay, Human Chorionic Gonadotropin   More FDA Info for this Device
510(K) Number	K041946
Device Name	Radioimmunoassay, Human Chorionic Gonadotropin
Applicant	ACON LABORATORIES, INC. 4108 SORRENTO VALLEY BLVD. SAN DIEGO, CA 92121 US Other 510(k) Applications for this Company
Contact	EDWARD TUNG, PH.D. Other 510(k) Applications for this Contact
Regulation Number	862.1155   More FDA Info for this Regulation Number
Classification Product Code	JHI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/19/2004
Decision Date	08/16/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review