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510(k) K924006

BARTEL PRIMA SYSTEM INFLUENZA A ENZYME IMMUNOASSAY by Baxter Healthcare Corp — Product Code GNX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 1992
Date Received
August 10, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigens, Cf (Including Cf Control), Influenza Virus A, B, C
Device Class
Class I
Regulation Number
866.3330
Review Panel
MI
Submission Type

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  • K971494 — VIRAZYME INFLUENZA ID TEST FOR INFLUENZA TYPES A AND B VIRUSES (September 10, 1997)
  • K901493 — FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE B (June 27, 1990)
  • K893579 — FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE A (January 16, 1990)