FDA 510(k) Application Details - K013757

Device Classification Name	Colorimetry, Acetaminophen   More FDA Info for this Device
510(K) Number	K013757
Device Name	Colorimetry, Acetaminophen
Applicant	ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. INDIANAPOLIS, IN 46250 US Other 510(k) Applications for this Company
Contact	MIKE FLIS Other 510(k) Applications for this Contact
Regulation Number	862.3030   More FDA Info for this Regulation Number
Classification Product Code	LDP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/13/2001
Decision Date	01/08/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review