SR1 T3 Uptake Enzyme Immunoassay (Mag Solid-Phase)

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K911912 ↗

FDA Product Code

KHQ

Device Class

Class II

Regulation

21 CFR Part 862.1715

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Progesterone Maia Radioimmuno Assay Kit Mag Sld Ph

  Class I

  FDA 510(k) K873431 Active Cleared 20 Oct 1987

• Estradiol Maiaclone Radioimmunoassay Kit

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  FDA 510(k) K890645 Active Cleared 8 Mar 1989

• SR1 T4 Enzyme Immunoassay (Magnetic Solid-Phase)

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  FDA 510(k) K911217 Active Cleared 16 Aug 1991

• SR1 Estradiol Enzyme Immunoassay

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• C-Peptide Radioimmunoassay Test Kit

  Class I

  FDA 510(k) K833396 Active Cleared 13 Apr 1984

• Prolactin Maiaclone Immunoradio. Kit, Mag Sol Pha

  Class I

  FDA 510(k) K873400 Active Cleared 25 Sep 1987

See all devices from Serono Diagnostics, Inc. →

• What is the SR1 T3 Uptake Enzyme Immunoassay used for?

  The SR1 T3 Uptake Enzyme Immunoassay is a radioassay that measures available thyroid hormone binding sites by assessing triiodothyronine (T3) uptake, which helps evaluate thyroid function in clinical laboratory settings.

• How is the SR1 T3 Uptake Enzyme Immunoassay supplied and what technology does it use?

  The device is supplied as a test kit for in vitro diagnostic use and employs enzyme immunoassay technology with magnetic solid-phase separation to measure T3 uptake.

• Is the SR1 T3 Uptake Enzyme Immunoassay cleared for use and what is its regulatory pathway?

  The device received FDA 510(k) clearance (K911912) as substantially equivalent to a legally marketed predicate device, following a traditional clearance pathway for in vitro diagnostic use in clinical laboratories.