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FDA 510(k) Application Details - K962410
Device Classification Name
Calibrator, Multi-Analyte Mixture
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510(K) Number
K962410
Device Name
Calibrator, Multi-Analyte Mixture
Applicant
BEHRING DIAGNOSTICS, INC.
151 UNIVERSITY AVE.
WESTWOOD, MA 02090 US
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Contact
KATHLEEN DRAY-LYONS
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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
06/21/1996
Decision Date
07/16/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
HE - Hematology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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