FDA 510(k) Application Details - K964982

Device Classification Name	Radioimmunoassay, Luteinizing Hormone   More FDA Info for this Device
510(K) Number	K964982
Device Name	Radioimmunoassay, Luteinizing Hormone
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	862.1485   More FDA Info for this Regulation Number
Classification Product Code	CEP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/12/1996
Decision Date	02/20/1997
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