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510(k) K853307

DIRECT ELISA FOR HERPES SIMPLEX VIRUS by Fairleigh Dickinson Laboratories, Inc. — Product Code GQN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 1985
Date Received
August 7, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2
Device Class
Class II
Regulation Number
866.3305
Review Panel
MI
Submission Type

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  • K850251 — ROTALOK SURGICAL HAND TABLE (February 28, 1985)

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