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510(k) K132515

LIAISON N-TACT PTH GEN II, CONTROL SET, CALIBRATION VERIFIERS by DiaSorin, Inc. — Product Code CEW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 2013
Date Received
August 12, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Parathyroid Hormone
Device Class
Class II
Regulation Number
862.1545
Review Panel
CH
Submission Type

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