FDA 510(k) Application Details - K971921

Device Classification Name	Radioimmunoassay, Prolactin (Lactogen)   More FDA Info for this Device
510(K) Number	K971921
Device Name	Radioimmunoassay, Prolactin (Lactogen)
Applicant	MONOBIND 729 WEST 16TH ST., C-4 COSTA MESA, CA 92627 US Other 510(k) Applications for this Company
Contact	DREDERICK R JEROME Other 510(k) Applications for this Contact
Regulation Number	862.1625   More FDA Info for this Regulation Number
Classification Product Code	CFT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/23/1997
Decision Date	06/24/1997
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