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510(k) K842071

FIAX TRANSFERRIN TEST KIT by Intl. Diagnostic Technology — Product Code DDI

K842071 is an FDA 510(k) premarket notification submitted by Intl. Diagnostic Technology for the device "FIAX TRANSFERRIN TEST KIT". The FDA issued a decision of Substantially Equivalent on July 11, 1984. The device falls under product code DDI (Transferrin, Fitc, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5880. Intl. Diagnostic Technology has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 1984
Date Received
May 23, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transferrin, Fitc, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5880
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)
  • 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)
  • K832821 — FIAX IGG TEST (October 14, 1983)

Other clearances for product code DDI

  • K772074 — RADIAL IMMUNODIFFUSION KIT-TRANSFERRIN (February 3, 1978)

FDA data resources