Immo Phase FT4 Assay

No FDA recalls on record, checked 12 Oct 2026.

510(k) Number

K772194 ↗

FDA Product Code

CEC

Device Class

Class II

Regulation

21 CFR Part 862.1695

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Isoenzyme Serum Control

  Class I

  FDA 510(k) K780147 Active Cleared 23 Feb 1978

• Ria Kit, Immo Phase

  Class II

  FDA 510(k) K781953 Active Cleared 1 Feb 1979

• Vitamin B12 57CO/Folate 125I -

  Class II

  FDA 510(k) K840462 Active Cleared 25 Jun 1984

• Immo Phase, Thyroid Hormone

  Class II

  FDA 510(k) K781409 Active Cleared 27 Sep 1978

• Corning 60 Volt Power Supply

  Class I

  FDA 510(k) K801893 Active Cleared 16 Sep 1980

• Electrophoresis Power Supply Tester

  Class I

  FDA 510(k) K771322 Active Cleared 18 Oct 1977

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