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FDA 510(k) Application Details - K973202
Device Classification Name
Ferritin, Antigen, Antiserum, Control
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510(K) Number
K973202
Device Name
Ferritin, Antigen, Antiserum, Control
Applicant
BEHRING DIAGNOSTICS, INC.
151 UNIVERSITY AVE.
WESTWOOD, MA 02090 US
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Contact
Ruth Forstadt
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Regulation Number
866.5340
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Classification Product Code
DBF
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Date Received
07/08/1997
Decision Date
09/12/1997
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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