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510(k) K143075

ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator Set by Tosoh Bioscience, Inc. — Product Code CDZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 2015
Date Received
October 27, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Testosterones And Dihydrotestosterone
Device Class
Class I
Regulation Number
862.1680
Review Panel
CH
Submission Type

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