FDA 510(k) Application Details - K991795

Device Classification Name	Immunoassay Method, Troponin Subunit   More FDA Info for this Device
510(K) Number	K991795
Device Name	Immunoassay Method, Troponin Subunit
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	MMI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/26/1999
Decision Date	06/09/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review