FDA 510(k) Application Details - K974262

Device Classification Name	Kit, Serological, Positive Control   More FDA Info for this Device
510(K) Number	K974262
Device Name	Kit, Serological, Positive Control
Applicant	SCANTIBODIES LABORATORY, INC. 9336 ABRAHAM WAY SANTEE, CA 92071 US Other 510(k) Applications for this Company
Contact	RICHARD LENART Other 510(k) Applications for this Contact
Regulation Number	862.1660   More FDA Info for this Regulation Number
Classification Product Code	MJX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/13/1997
Decision Date	12/24/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review