FDA 510(k) Application Details - K983147

Device Classification Name	Reagents, Test, Tetrahydrocannabinol   More FDA Info for this Device
510(K) Number	K983147
Device Name	Reagents, Test, Tetrahydrocannabinol
Applicant	PRINCETON BIOMEDITECH CORP. P.O. BOX 7139 PRINCETON, NJ 08543-7139 US Other 510(k) Applications for this Company
Contact	JEMO KANG Other 510(k) Applications for this Contact
Regulation Number	862.3870   More FDA Info for this Regulation Number
Classification Product Code	DKE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/08/1998
Decision Date	09/28/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review