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510(k) K041866

ABBOTT AXSYM TESTOSTERONE MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) by Axis-Shield Diagnostics, Ltd. — Product Code CDZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 2004
Date Received
July 9, 2004
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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