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FDA 510(k) Application Details - K103716
Device Classification Name
Acid, Folic, Radioimmunoassay
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510(K) Number
K103716
Device Name
Acid, Folic, Radioimmunoassay
Applicant
Roche Diagnostics
9115 Hague Road
Indianapolis, IN 46250 US
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Contact
KATHIE J GOODWIN
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Regulation Number
862.1295
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Classification Product Code
CGN
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More FDA Info for this Product Code
Date Received
12/21/2010
Decision Date
05/12/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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