FDA 510(k) Application Details - K972133

Device Classification Name	Radioimmunoassay, Progesterone   More FDA Info for this Device
510(K) Number	K972133
Device Name	Radioimmunoassay, Progesterone
Applicant	JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. 100 INDIGO CREEK DR. ROCHESTER, NY 14650-0882 US Other 510(k) Applications for this Company
Contact	ANN M QUINN 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	06/06/1997
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	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review