FDA 510(k) Application Details - K973898

Device Classification Name	Radioimmunoassay, Progesterone   More FDA Info for this Device
510(K) Number	K973898
Device Name	Radioimmunoassay, Progesterone
Applicant	KMI DIAGNOSTICS, INC. 818 51ST AVE., N.E. SUITE 101 MINNEAPOLIS, MN 55421 US Other 510(k) Applications for this Company
Contact	MARK A KOWAL Other 510(k) Applications for this Contact
Regulation Number	862.1620   More FDA Info for this Regulation Number
Classification Product Code	JLS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/14/1997
Decision Date	11/13/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review