FDA 510(k) Application Details - K960233

Device Classification Name	Radioimmunoassay, Luteinizing Hormone   More FDA Info for this Device
510(K) Number	K960233
Device Name	Radioimmunoassay, Luteinizing Hormone
Applicant	VANGUARD BIOMEDICAL CORP. 10225 BARNES CANYON RD., SUITE A-108 SAN DIEGO, CA 92121 US Other 510(k) Applications for this Company
Contact	JOHN CHJIU 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	01/17/1996
Decision Date	04/23/1996
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