FDA 510(k) Application Details - K013272

Device Classification Name	Enzyme Immunoassay, Theophylline   More FDA Info for this Device
510(K) Number	K013272
Device Name	Enzyme Immunoassay, Theophylline
Applicant	BAYER CORP. 511 BENEDICT AVE. TARRYTOWN, NY 10591-5097 US Other 510(k) Applications for this Company
Contact	KENNETH T EDDS Other 510(k) Applications for this Contact
Regulation Number	862.3880   More FDA Info for this Regulation Number
Classification Product Code	KLS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/01/2001
Decision Date	10/25/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review