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510(k) K831607

FIAX IGA TEST KIT by Intl. Diagnostic Technology — Product Code CZN

K831607 is an FDA 510(k) premarket notification submitted by Intl. Diagnostic Technology for the device "FIAX IGA TEST KIT". The FDA issued a decision of Substantially Equivalent on June 22, 1983. The device falls under product code CZN (Iga, Fitc, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5510. Intl. Diagnostic Technology has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1983
Date Received
May 18, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Iga, Fitc, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5510
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 CZN

  • K891683 — TITAN GEL IFE FREE KAPPA/LAMBA LIGHT CHAIN ANTISER (April 12, 1989)
  • K855011 — QUANTIMETRIC PLUS C3 REAGENT KIT (February 26, 1986)
  • K841815 — OPTIMATE IGA TEST (June 1, 1984)
  • K832262 — FITC GOAT ANTI-HUMAN IMMUNOGLOBULINS (October 31, 1983)
  • K832257 — GOAT ANTI-HUMAN IGA A CHAIN SPECIFIC (October 28, 1983)
  • K831909 — RABBIT ANTISERUM TO HUMAN IGA (July 18, 1983)

FDA data resources