FDA 510(k) Application Details - K991299

Device Classification Name	Chromatographic Separation, Cpk Isoenzymes   More FDA Info for this Device
510(K) Number	K991299
Device Name	Chromatographic Separation, Cpk Isoenzymes
Applicant	PRINCETON BIOMEDITECH CORP. 4242 U.S. RT. 1 MONMOUTH JUNCTION, NJ 08852-1905 US Other 510(k) Applications for this Company
Contact	JEMO KANG Other 510(k) Applications for this Contact
Regulation Number	862.1215   More FDA Info for this Regulation Number
Classification Product Code	JHT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/06/1999
Decision Date	05/28/1999
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