Home / 510(k) Clearances / K842071

510(k) K842071

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

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)