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FDA 510(k) Application Details - K012371
Device Classification Name
Transferrin, Antigen, Antiserum, Control
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510(K) Number
K012371
Device Name
Transferrin, Antigen, Antiserum, Control
Applicant
ROCHE DIAGNOSTICS CORP.
9115 HAGUE RD.
INDIANAPOLIS, IN 46250-0457 US
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Contact
SHERRI L COENEN
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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
07/26/2001
Decision Date
09/19/2001
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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