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510(k) K052649

DRG SLV TESTOSTERONE ELISA TEST by Drg Intl., Inc. — Product Code CDZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 2006
Date Received
September 26, 2005
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

Other clearances by Drg Intl., Inc.

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  • K000043 — DRG AURICA ELISA TESTOSTERONE KIT (April 17, 2000)

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