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510(k) K002294

BIOCHECK TESTOSTERONE EIA, MODEL BC-1115 by Biocheck, Inc. — Product Code CDZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 2, 2000
Date Received
July 27, 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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