FDA 510(k) Application Details - K022829

Device Classification Name	Radioimmunoassay, Luteinizing Hormone   More FDA Info for this Device
510(K) Number	K022829
Device Name	Radioimmunoassay, Luteinizing Hormone
Applicant	ALFA SCIENTIFIC DESIGNS, INC. 12330 STOWE DR. POWAY, CA 92064 US Other 510(k) Applications for this Company
Contact	NAISHU WANG 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	08/26/2002
Decision Date	11/05/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review