Fiax Igm Test Kit

No FDA recalls on record, checked 10 Oct 2026.

510(k) Number

K831608 ↗

FDA Product Code

DFT

Device Class

Class II

Regulation

21 CFR Part 866.5550

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K830668 Active Cleared 5 Apr 1983

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  Class I

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• Fiax Igg Test Kit

  Class II

  FDA 510(k) K831609 Active Cleared 17 Jun 1983

• Antinuclear Antibody Immunological

  Class II

  FDA 510(k) K833984 Active Cleared 4 Jan 1984

See all devices from Intl. Diagnostic Technology →