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510(k) K893579

FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE A by Whittaker Bioproducts, Inc. — Product Code GNX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 16, 1990
Date Received
May 9, 1989
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

Other clearances by Whittaker Bioproducts, Inc.

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  • K904652 — LYME STAT M TEST KIT (October 21, 1991)
  • K904893 — FIAX LYME M TEST KIT (October 16, 1991)
  • K911473 — EBNA STAT TEST KIT (September 25, 1991)
  • K905468 — PYLORI-G FIAX TEST KIT (May 7, 1991)
  • K904738 — PYLORI STAT TEST KIT (May 7, 1991)
  • K901493 — FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE B (June 27, 1990)
  • K894932 — FIAX EB VCA-M TEST KIT (October 16, 1989)
  • K894235 — EB VCA STAT M TEST KIT (August 30, 1989)

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  • K123182 — OSOM INFLUENZA A&B TEST MODEL 190 (November 5, 2012)
  • K971494 — VIRAZYME INFLUENZA ID TEST FOR INFLUENZA TYPES A AND B VIRUSES (September 10, 1997)
  • K924006 — BARTEL PRIMA SYSTEM INFLUENZA A ENZYME IMMUNOASSAY (December 29, 1992)
  • K901493 — FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE B (June 27, 1990)