FDA 510(k) Application Details - K961412

Device Classification Name	Colorimetric Method, Cpk Or Isoenzymes   More FDA Info for this Device
510(K) Number	K961412
Device Name	Colorimetric Method, Cpk Or Isoenzymes
Applicant	BAYER CORP. 511 BENEDICT AVE. TARRYTOWN, NY 10591-5097 US Other 510(k) Applications for this Company
Contact	GABRIEL J MURACA, JR. 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	04/12/1996
Decision Date	06/18/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review