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510(k) K901493

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 1990
Date Received
March 29, 1990
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)
  • K904738 — PYLORI STAT TEST KIT (May 7, 1991)
  • K905468 — PYLORI-G FIAX TEST KIT (May 7, 1991)
  • K893579 — FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE A (January 16, 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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  • K893579 — FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE A (January 16, 1990)