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510(k) K896635

VIRAL RESPIRATORY INDIRECT FLUORES. MONO. ANTIBODY by Baxter Healthcare Corp — Product Code GNW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 2, 1990
Date Received
November 22, 1989
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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