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510(k) K843659

INFLUENZA A2 VIRUS by Institute Virion , Ltd. — Product Code GNX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 1985
Date Received
September 17, 1984
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 Institute Virion , Ltd.

  • K862814 — COMPLEMENT-FIXATION TEST FOR CAMPYLOBACTER JEJUNI (September 30, 1986)
  • K843657 — CYTOMEGALOVIRUS (September 26, 1985)
  • K843665 — PARAINFLUENZA 1 (September 26, 1985)
  • K843649 — ADENOVIRUS (September 26, 1985)
  • K843673 — RESPIRATORY SYNCYTIAL VIRUS (September 26, 1985)
  • K843658 — H. SIMPLEX VIRUS (September 26, 1985)
  • K843662 — MEASLES VIRUS RUBEOLA (September 26, 1985)
  • K843667 — PARAINFLUENZA 3 (September 26, 1985)
  • K843660 — IN FLUENZA B VIRUS (September 26, 1985)
  • K843676 — VARICELLA/ZOSTER VIRUS (September 26, 1985)

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  • K924006 — BARTEL PRIMA SYSTEM INFLUENZA A ENZYME IMMUNOASSAY (December 29, 1992)
  • K901493 — FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE B (June 27, 1990)