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FDA 510(k) Application Details - K033426
Device Classification Name
Radioimmunoassay, Parathyroid Hormone
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510(K) Number
K033426
Device Name
Radioimmunoassay, Parathyroid Hormone
Applicant
DIASORIN, INC.
1951 NORTHWESTERN AVE.
P.O. BOX 285
STILLWATER, MN 55082 US
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Contact
DAVID M IKEDA
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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
10/27/2003
Decision Date
02/12/2004
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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