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510(k) K932951

DELFIA TESTTOSTERONE KIT by Wallac OY — Product Code CDZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 1993
Date Received
June 17, 1993
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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