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FDA 510(k) Application Details - K132515
Device Classification Name
Radioimmunoassay, Parathyroid Hormone
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510(K) Number
K132515
Device Name
Radioimmunoassay, Parathyroid Hormone
Applicant
DIASORIN, INC.
1951 NORTHWESTERN AVE.
STILLWATER, MN 55082-0285 US
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Contact
CAROL A DEPOUW
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Regulation Number
862.1545
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Classification Product Code
CEW
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More FDA Info for this Product Code
Date Received
08/12/2013
Decision Date
11/08/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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