FDA 510(k) Application Details - K963181

Device Classification Name	Single (Specified) Analyte Controls (Assayed And Unassayed)   More FDA Info for this Device
510(K) Number	K963181
Device Name	Single (Specified) Analyte Controls (Assayed And Unassayed)
Applicant	BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD. P.O. BOX 50457 INDIANAPOLIS, IN 46250-0457 US Other 510(k) Applications for this Company
Contact	JOHN D STEVENS 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	08/14/1996
Decision Date	09/10/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review