FDA 510(k) Application Details - K980012

Device Classification Name	Fluorometric Method, Cpk Or Isoenzymes   More FDA Info for this Device
510(K) Number	K980012
Device Name	Fluorometric Method, Cpk Or Isoenzymes
Applicant	AC BIOCHEMICALS, INC. 17955 SKY PARK CIRCLE, SUITE J IRVINE, CA 92614 US Other 510(k) Applications for this Company
Contact	CHARLES C ALLAIN Other 510(k) Applications for this Contact
Regulation Number	862.1215   More FDA Info for this Regulation Number
Classification Product Code	JHX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/02/1998
Decision Date	02/25/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review