FDA 510(k) Application Details - K980153

Device Classification Name	Enzyme Immunoassay, Cocaine And Cocaine Metabolites   More FDA Info for this Device
510(K) Number	K980153
Device Name	Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Applicant	TEXAS IMMUNOLOGY, INC. 5400 SPUR 248 TYLER, TX 75707 US Other 510(k) Applications for this Company
Contact	CHARLES W GILL Other 510(k) Applications for this Contact
Regulation Number	862.3250   More FDA Info for this Regulation Number
Classification Product Code	DIO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/16/1998
Decision Date	03/27/1998
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