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510(k) K803132

HERPES SIMPLEX VIRUS SEROLOGICAL REAGENT by Microbiological Research Corp. — Product Code GQL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 1981
Date Received
December 12, 1980
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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