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510(k) K120009

TESTOSTERONE TEST SYSTEM; CALIBRATOR; AND QUALITY CONTROL MATERIAL (ASSAYED AND UNASSAYED) by Abbott Laboratories — Product Code CDZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 2012
Date Received
January 3, 2012
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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