FDA 510(k) Application Details - K965227

Device Classification Name	Radioimmunoassay, Human Chorionic Gonadotropin   More FDA Info for this Device
510(K) Number	K965227
Device Name	Radioimmunoassay, Human Chorionic Gonadotropin
Applicant	WYNTEK DIAGNOSTICS, INC. 6145 NANCY RIDGE DR. SUITE 101 SAN DIEGO, CA 92121 US Other 510(k) Applications for this Company
Contact	SHU-CHING CHENG 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	12/30/1996
Decision Date	02/04/1997
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