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FDA 510(k) Application Details - K965157
Device Classification Name
Drug Mixture Control Materials
More FDA Info for this Device
510(K) Number
K965157
Device Name
Drug Mixture Control Materials
Applicant
BOEHRINGER MANNHEIM CORP.
2400 BISSO LN.
P.O. BOX 4117
CONCORD, CA 94524-4117 US
Other 510(k) Applications for this Company
Contact
Yvette Lloyd
Other 510(k) Applications for this Contact
Regulation Number
862.3280
More FDA Info for this Regulation Number
Classification Product Code
DIF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/23/1996
Decision Date
01/17/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
TX - Clinical Toxicology
Review Advisory Committee
TX - Clinical Toxicology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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