FDA 510(k) Application Details - K981363

Device Classification Name	Enzyme Immunoassay, Phencyclidine   More FDA Info for this Device
510(K) Number	K981363
Device Name	Enzyme Immunoassay, Phencyclidine
Applicant	TCPI, INC. P.O. BOX 8726 FT. LAUDERDALE, FL 33310 US Other 510(k) Applications for this Company
Contact	JEFFREY BOLTS 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	04/15/1998
Decision Date	12/22/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review