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510(k) K832821

FIAX IGG TEST by Intl. Diagnostic Technology — Product Code DFI

K832821 is an FDA 510(k) premarket notification submitted by Intl. Diagnostic Technology for the device "FIAX IGG TEST". The FDA issued a decision of Substantially Equivalent on October 14, 1983. The device falls under product code DFI (Total Spinal-Fluid, Antigen, Antiserum, Control), a Class I device regulated under 21 CFR 866.5860. Intl. Diagnostic Technology has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 14, 1983
Date Received
August 19, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Total Spinal-Fluid, Antigen, Antiserum, Control
Device Class
Class I
Regulation Number
866.5860
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)

Other clearances for product code DFI

  • K854190 — CANTROL SPINAL FLUID CONTROL (November 25, 1985)
  • K843122 — RESOLVE-CSF (November 30, 1984)
  • K840974 — SOMAS HUMAN SPINAL FLUID CONTROL (April 5, 1984)

FDA data resources