FDA 510(k) Application Details - K972182

Device Classification Name	Kit, Direct Antigen, Positive Control   More FDA Info for this Device
510(K) Number	K972182
Device Name	Kit, Direct Antigen, Positive Control
Applicant	ABBOTT DIAGNOSTICS 200 ABBOTT PARK RD. DEPT. 9V6, BLDG. AP31 ABBOTT PARK, IL 60064-3537 US Other 510(k) Applications for this Company
Contact	GRACE LEMIEUX Other 510(k) Applications for this Contact
Regulation Number	862.1660   More FDA Info for this Regulation Number
Classification Product Code	MJZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/29/1997
Decision Date	08/13/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review