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510(k) K000043

DRG AURICA ELISA TESTOSTERONE KIT by Drg Intl., Inc. — Product Code CDZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 2000
Date Received
January 6, 2000
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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