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510(k) K971502

SERODIA TP-PA by Scimedx Tekfile Services — Product Code GMT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 1997
Date Received
April 24, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigens, Ha, Treponema Pallidum
Device Class
Class II
Regulation Number
866.3830
Review Panel
MI
Submission Type

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