FDA 510(k) Application Details - K013857

Device Classification Name	System, Test, Human Chorionic Gonadotropin   More FDA Info for this Device
510(K) Number	K013857
Device Name	System, Test, Human Chorionic Gonadotropin
Applicant	GERMAINE LABORATORIES, INC. 4139 GARDENDALE CENTER, SUITE 101 SAN ANTONIO, TX 78229 US Other 510(k) Applications for this Company
Contact	MARTIN O'CONNOER Other 510(k) Applications for this Contact
Regulation Number	862.1155   More FDA Info for this Regulation Number
Classification Product Code	DHA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/21/2001
Decision Date	01/22/2002
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