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FDA 510(k) Application Details - K051292
Device Classification Name
Acid, Folic, Radioimmunoassay
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510(K) Number
K051292
Device Name
Acid, Folic, Radioimmunoassay
Applicant
ROCHE DIAGNOSTICS CORP.
9115 HAGUE RD.
INDIANAPOLIS, IN 46250 US
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Contact
KAY A TAYLOR
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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
05/18/2005
Decision Date
06/17/2005
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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