FDA 510(k) Application Details - K965084

Device Classification Name	Radioimmunoassay, Progesterone   More FDA Info for this Device
510(K) Number	K965084
Device Name	Radioimmunoassay, Progesterone
Applicant	BIOMERIEUX, INC. 1022 HINGHAM ST. ROCKLAND, MA 02370 US Other 510(k) Applications for this Company
Contact	TERRY MCGOVERN 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	12/19/1996
Decision Date	01/09/1997
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