FDA 510(k) Application Details - K991277

Device Classification Name	Myoglobin, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K991277
Device Name	Myoglobin, Antigen, Antiserum, Control
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	866.5680   More FDA Info for this Regulation Number
Classification Product Code	DDR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/14/1999
Decision Date	04/27/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review