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510(k) K850739

AMENDMENT TO LABELING MICROTRAK HSV 1/HSV 2 DIRECT by Syva Co. — Product Code GQL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 1985
Date Received
February 15, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, Fluorescent, Herpesvirus Hominis 1,2
Device Class
Class II
Regulation Number
866.3305
Review Panel
MI
Submission Type

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