FDA 510(k) Application Details - K974811

Device Classification Name	Single (Specified) Analyte Controls (Assayed And Unassayed)   More FDA Info for this Device
510(K) Number	K974811
Device Name	Single (Specified) Analyte Controls (Assayed And Unassayed)
Applicant	BOSTON BIOMEDICA, INC. 375 WEST ST. WEST BRIDGEWATER, MA 02379 US Other 510(k) Applications for this Company
Contact	PATRICIA E GARRETT Other 510(k) Applications for this Contact
Regulation Number	862.1660   More FDA Info for this Regulation Number
Classification Product Code	JJX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/23/1997
Decision Date	02/10/1998
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