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FDA 510(k) Application Details - K963191
Device Classification Name
Calibrators, Drug Mixture
More FDA Info for this Device
510(K) Number
K963191
Device Name
Calibrators, Drug Mixture
Applicant
BOEHRINGER MANNHEIM CORP.
2400 BISSO LN.
P.O. BOX 4117
CONCORD, CA 94524-4117 US
Other 510(k) Applications for this Company
Contact
BETSY SOARES-MADDOX
Other 510(k) Applications for this Contact
Regulation Number
862.3200
More FDA Info for this Regulation Number
Classification Product Code
DKB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/15/1996
Decision Date
09/10/1996
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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