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FDA 510(k) Application Details - K974384
Device Classification Name
Multi-Analyte Controls, All Kinds (Assayed)
More FDA Info for this Device
510(K) Number
K974384
Device Name
Multi-Analyte Controls, All Kinds (Assayed)
Applicant
BOEHRINGER MANNHEIM CORP.
4300 HACIENDA DR.
PLEASANTON, CA 94588-2722 US
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Contact
Patricia M Klimley
Other 510(k) Applications for this Contact
Regulation Number
862.1660
More FDA Info for this Regulation Number
Classification Product Code
JJY
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More FDA Info for this Product Code
Date Received
11/21/1997
Decision Date
12/08/1997
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
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