FDA 510(k) Application Details - K990249

Device Classification Name	Radioimmunoassay, Luteinizing Hormone   More FDA Info for this Device
510(K) Number	K990249
Device Name	Radioimmunoassay, Luteinizing Hormone
Applicant	PHAMATECH 9265 ACTIVITY RD., #112-113 SAN DIEGO, CA 92126 US Other 510(k) Applications for this Company
Contact	CARL MONGIOVI 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	01/26/1999
Decision Date	03/22/1999
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