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510(k) K905608

INDIRECT FLUORESCENT ASSAY FOR HERPES SIMPLEX 1 by Stellar Bio Systems, Inc. — Product Code GQL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 1991
Date Received
December 14, 1990
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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  • K882835 — INDIRECT FLUORESCENT ASSAY FOR (HCMV) (December 5, 1988)

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