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FDA 510(k) Application Details - K983880
Device Classification Name
Transferrin, Antigen, Antiserum, Control
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510(K) Number
K983880
Device Name
Transferrin, Antigen, Antiserum, Control
Applicant
DIASORIN, INC.
9175 GUIFORD RD.
COLUMBIA, MD 21046 US
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Contact
JUDITH J SMITH
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Regulation Number
866.5880
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Classification Product Code
DDG
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More FDA Info for this Product Code
Date Received
11/02/1998
Decision Date
12/18/1998
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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