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FDA 510(k) Application Details - K013249
Device Classification Name
Alpha-1-Lipoprotein, Antigen, Antiserum, Control
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510(K) Number
K013249
Device Name
Alpha-1-Lipoprotein, Antigen, Antiserum, Control
Applicant
ROCHE DIAGNOSTICS CORP.
9115 HAGUE RD.
INDIANAPOLIS, IN 46256 US
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Contact
HELEN T TORNEY
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Regulation Number
866.5580
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Classification Product Code
DER
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More FDA Info for this Product Code
Date Received
09/28/2001
Decision Date
11/16/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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