FDA 510(k) Application Details - K980532

Device Classification Name	Kit, Test, Pregnancy, Hcg, Over The Counter   More FDA Info for this Device
510(K) Number	K980532
Device Name	Kit, Test, Pregnancy, Hcg, Over The Counter
Applicant	PHAMATECH 9265 ACTIVITY RD., #112-113 SAN DIEGO, CA 92126 US Other 510(k) Applications for this Company
Contact	CARL A MONGIOVI Other 510(k) Applications for this Contact
Regulation Number	862.1155   More FDA Info for this Regulation Number
Classification Product Code	LCX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/11/1998
Decision Date	03/11/1998
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