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510(k) K913351

INFLUENZA MAB TEST/INFLUENZA A TEST by Gull Laboratories, Inc. — Product Code GNW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 1991
Date Received
July 26, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, Cf, Influenza Virus A, B, C
Device Class
Class I
Regulation Number
866.3330
Review Panel
MI
Submission Type

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