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510(k) K843673

RESPIRATORY SYNCYTIAL VIRUS by Institute Virion , Ltd. — Product Code GQG

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
Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
Device Class
Class I
Regulation Number
866.3480
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)
  • K843660 — IN FLUENZA B VIRUS (September 26, 1985)
  • K843658 — H. SIMPLEX VIRUS (September 26, 1985)
  • K843662 — MEASLES VIRUS RUBEOLA (September 26, 1985)
  • K843659 — INFLUENZA A2 VIRUS (September 26, 1985)
  • K843667 — PARAINFLUENZA 3 (September 26, 1985)
  • K843649 — ADENOVIRUS (September 26, 1985)
  • K843676 — VARICELLA/ZOSTER VIRUS (September 26, 1985)

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