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510(k) K063605

ST AIA-PACK INTACT PTH ASSAY by Tosoh Bioscience, Inc. — Product Code CEW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 2007
Date Received
December 4, 2006
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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