Thyro-Shure

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

510(k) Number

K781296 ↗

FDA Product Code

JLW

Device Class

Class II

Regulation

21 CFR Part 862.1690

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Nml Tsh Irma

  Class II

  FDA 510(k) K852438 Active Cleared 12 Jul 1985

• Choric-Shure

  Class II

  FDA 510(k) K790138 Active Cleared 12 Mar 1979

• Compu-Pet 300

  Class I

  FDA 510(k) K761290 Active Cleared 24 Feb 1977

• Nml 6000 CT

  Class I

  FDA 510(k) K823679 Active Cleared 7 Jan 1983

• Nml-Tetra-Tube Ria

  Class II

  FDA 510(k) K823053 Active Cleared 10 Nov 1982

• Diagnostic Radioimmunoassay for Quanti

  Class II

  FDA 510(k) K822298 Active Cleared 2 Sep 1982

See all devices from Nuclear Medical Laboratories, Inc. →

• What is the Thyroid-Stimulating Hormone Radioimmunoassay Kit used for in clinical practice?

  The Thyroid-Stimulating Hormone Radioimmunoassay Kit is designed to measure TSH levels in serum or plasma, aiding in the diagnosis and monitoring of thyroid disorders such as hypothyroidism and hyperthyroidism. By quantifying TSH concentrations using radioactive isotopes, it provides precise results to support clinical decision-making in endocrinology.

• Is the Thyroid-Stimulating Hormone Radioimmunoassay Kit intended for single-use or repeated use?

  The kit is explicitly supplied as a single-use diagnostic device, meaning each kit is intended for one-time use only. This ensures sterile handling and compliance with radiation safety protocols, as reuse could compromise accuracy and pose safety risks.

• What safety considerations must be followed when using this device?

  Due to its radioactive components, the Thyroid-Stimulating Hormone Radioimmunoassay Kit requires strict adherence to radiation safety protocols during handling and use. Sterile techniques must also be followed, as it is intended for clinical chemistry laboratories. Storage must comply with radioactive material regulations to maintain safety and integrity.

• How is this device regulated, and what does its classification mean for users?

  The kit is classified under FDA product code JLW and falls under Class II regulatory requirements with special controls. It was cleared via a traditional 510(k) pathway (K781296) in 1978, meaning it was determined to be substantially equivalent to a legally marketed device. This classification ensures it meets specific performance standards and safety requirements for diagnostic use in clinical chemistry.

• Where and how should the Thyroid-Stimulating Hormone Radioimmunoassay Kit be stored?

  The kit must be stored in accordance with radioactive material regulations, as it contains radioactive isotopes. Proper storage conditions are critical to ensure the stability and safety of the components. Always follow manufacturer guidelines and local regulations for radioactive substance handling and storage.