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FDA 510(k) Application Details - K101921
Device Classification Name
Radioimmunoassay, Parathyroid Hormone
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510(K) Number
K101921
Device Name
Radioimmunoassay, Parathyroid Hormone
Applicant
ORTHO-CLINICAL DIAGNOSTICS
100 INDIGO CREEK DRIVE
ROCHESTER, NY 14626-0551 US
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Contact
DECLAN HYNES
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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
07/09/2010
Decision Date
10/22/2010
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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