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510(k) K942172

INFLUENZA A ANTIGEN TEST by Neogenex — Product Code GNW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 1994
Date Received
May 5, 1994
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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  • K973954 — IMAGEN RESPIRATORY SCREEN (December 22, 1997)
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  • K942174 — INFLUENZA B ANITGEN TEST (June 30, 1994)