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510(k) K812968

FIAX RHEUMATOID FACTOR TEST KIT by Intl. Diagnostic Technology — Product Code DHR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 1981
Date Received
October 22, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Rheumatoid Factor
Device Class
Class II
Regulation Number
866.5775
Review Panel
IM
Submission Type

Other clearances by Intl. Diagnostic Technology

  • K850591 — FIAX TOXO-M ANTIBODIES TEST KIT (April 30, 1985)
  • K843570 — FIAX HAPTOGLOBIN TEST KIT (October 5, 1984)
  • K843621 — FIAX 420 DILUTOR (September 28, 1984)
  • K843356 — FIAX 100 FLUOROMETER (September 17, 1984)
  • K842749 — FIAX TOTAL IGE TEST KIT (August 28, 1984)
  • K842071 — FIAX TRANSFERRIN TEST KIT (July 11, 1984)
  • K841174 — RUBELLA ANTIBODY FLUOROIMMUNOASSAY (June 7, 1984)
  • K840867 — ALPHA-1-ANTITRYPSIN, FITC, ANTIGEN (May 11, 1984)
  • K834140 — ANTINUCLEAR ANTIBODY IMMUNOLOGICAL SYS (January 20, 1984)
  • K833984 — ANTINUCLEAR ANTIBODY IMMUNOLOGICAL (January 4, 1984)

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