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FDA 510(k) Application Details - K100853
Device Classification Name
Albumin, Antigen, Antiserum, Control
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510(K) Number
K100853
Device Name
Albumin, Antigen, Antiserum, Control
Applicant
ROCHE DIAGNOSTICS CORP.
9115 HAGUE RD.
INDIANAPOLIS, IN 46250 US
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Contact
ANGELO PEREIRA
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Regulation Number
866.5040
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Classification Product Code
DCF
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More FDA Info for this Product Code
Date Received
03/26/2010
Decision Date
09/09/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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