FDA 510(k) Application Details - K013582

Device Classification Name	Radioimmunoassay, Luteinizing Hormone   More FDA Info for this Device
510(K) Number	K013582
Device Name	Radioimmunoassay, Luteinizing Hormone
Applicant	MAYBE?MOM 22 CHURCH ST. SUITE 103-244 RAMSEY, NJ 07446 US Other 510(k) Applications for this Company
Contact	TONI MILLERVA 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	10/30/2001
Decision Date	01/16/2003
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