FDA 510(k) Application Details - K974421

Device Classification Name	Colorimetric Method, Cpk Or Isoenzymes   More FDA Info for this Device
510(K) Number	K974421
Device Name	Colorimetric Method, Cpk Or Isoenzymes
Applicant	BOEHRINGER MANNHEIM CORP. 4300 HACIENDA DR. PLEASANTON, CA 94588-2722 US Other 510(k) Applications for this Company
Contact	JODY J SAVAGE Other 510(k) Applications for this Contact
Regulation Number	862.1215   More FDA Info for this Regulation Number
Classification Product Code	JHY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/24/1997
Decision Date	12/17/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review