Corning Immo Phase Free T3

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K840222 ↗

FDA Product Code

CDP

Device Class

Class II

Regulation

21 CFR Part 862.1710

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

See all devices from Corning Medical & Scientific →

• What is the Corning Immo Phase Free T3 used for?

  The Corning Immo Phase Free T3 is a radioimmunoassay device designed to measure total triiodothyronine (T3) levels in clinical chemistry settings, aiding in thyroid function assessment.

• How is the Corning Immo Phase Free T3 supplied and is it sterile?

  The device is supplied by Corning Medical & Scientific; however, the provided data does not specify sterility or single-use/reuse status, so these details cannot be confirmed from the available information.

• What regulatory pathway was used for the Corning Immo Phase Free T3 clearance?

  The Corning Immo Phase Free T3 received FDA 510(k) clearance through the traditional pathway, with k-number K840222, and is classified as a Class II medical device under product code CDP.