FDA 510(k) Application Details - K980531

Device Classification Name	Radioimmunoassay, Human Chorionic Gonadotropin   More FDA Info for this Device
510(K) Number	K980531
Device Name	Radioimmunoassay, Human Chorionic Gonadotropin
Applicant	GERMAINE LABORATORIES, INC. 4203 GARDENDALE CENTER, #230 SAN ANTONIO, TX 78229 US Other 510(k) Applications for this Company
Contact	MARTIN O'CONNOR 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	02/11/1998
Decision Date	03/06/1998
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