FDA 510(k) Application Details - K004002

Device Classification Name	Fluorometric Method, Cpk Or Isoenzymes   More FDA Info for this Device
510(K) Number	K004002
Device Name	Fluorometric Method, Cpk Or Isoenzymes
Applicant	DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. LOS ANGELES, CA 90045-5597 US Other 510(k) Applications for this Company
Contact	EDWARD M LEVINE 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	12/26/2000
Decision Date	02/14/2001
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