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FDA 510(k) Application Details - K955596
Device Classification Name
System, Test, Beta-2-Microglobulin Immunological
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510(K) Number
K955596
Device Name
System, Test, Beta-2-Microglobulin Immunological
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
866.5630
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Classification Product Code
JZG
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More FDA Info for this Product Code
Date Received
12/08/1995
Decision Date
10/03/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
IM - Immunology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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