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510(k) K940449

DELFIA SHBG KIT by Wallac OY — Product Code CDZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 1994
Date Received
February 1, 1994
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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