FDA 510(k) Application Details - K041578

Device Classification Name	Enzyme Immunoassay, Phencyclidine   More FDA Info for this Device
510(K) Number	K041578
Device Name	Enzyme Immunoassay, Phencyclidine
Applicant	PHAMATECH 10151 BARNES CANYON ROAD SAN DIEGO, CA 92121 US Other 510(k) Applications for this Company
Contact	CARL MONGIOVI Other 510(k) Applications for this Contact
Regulation Number	862.3100   More FDA Info for this Regulation Number
Classification Product Code	LCM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/14/2004
Decision Date	09/10/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review