FDA 510(k) Application Details - K991386

Device Classification Name	Radioimmunoassay, Luteinizing Hormone   More FDA Info for this Device
510(K) Number	K991386
Device Name	Radioimmunoassay, Luteinizing Hormone
Applicant	SELFCARE, INC. 200 PROSPECT ST. WALTHAM, MA 02154-3457 US Other 510(k) Applications for this Company
Contact	Carol Adiletto 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	04/21/1999
Decision Date	05/25/1999
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