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510(k) K862483

PANTEX FTE FREE TESTOSTERONE RADIOIMMUNOASSAY KIT by Pantex, Div. Bio-Analysis, Inc. — Product Code CDZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 1987
Date Received
June 30, 1986
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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  • K862336 — PANCOAT CORTISOL COATED TUBE RADIOIMMUNOASSAY KIT (September 25, 1986)

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