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510(k) K830250

CVT VIRAL TRANSPORTS by Immulok, Inc. — Product Code JTW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 1983
Date Received
January 25, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Transport, Aerobic
Device Class
Class I
Regulation Number
866.2900
Review Panel
MI
Submission Type

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  • K822785 — FLUOROSET IMMUNOFLUORESCENT ANTIBODY (November 29, 1982)
  • K823055 — FLOUROSET IMMUNOFLUORESCENT ANTIBODY (November 5, 1982)
  • K822606 — CYTOMEGALOVIRUS ANTOBODY IGG (November 1, 1982)
  • K822605 — TOXOPLASMA GONDII ANTIBODY IGG (October 27, 1982)
  • K822607 — ANTINUCLEAR ANTOBODY CELL SUBSTRATE (September 17, 1982)
  • K821567 — IMMULOK CULTURESET (June 25, 1982)
  • K821411 — HISTOSET IMMUNOPEROFIDASE TISSUE (June 25, 1982)

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