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FDA 510(k) Application Details - K062334
Device Classification Name
Calibrator, Multi-Analyte Mixture
More FDA Info for this Device
510(K) Number
K062334
Device Name
Calibrator, Multi-Analyte Mixture
Applicant
DADE BEHRING, INC.
P.O. BOX BOX 6101, M/S 514
NEWARK, DE 19714-6101 US
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Contact
VICTOR M CARRIO
Other 510(k) Applications for this Contact
Regulation Number
862.1150
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Classification Product Code
JIX
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More FDA Info for this Product Code
Date Received
08/10/2006
Decision Date
09/22/2006
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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