Cyclic Adenosine Monophoshate by Radio

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

510(k) Number

K823504 ↗

FDA Product Code

CHO

Device Class

Class II

Regulation

21 CFR Part 862.1230

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Human Intract Parathyroid Hormone by

  Class II

  FDA 510(k) K830664 Active Cleared 9 May 1983

• Short Ragweed Allergen Disc

  Class II

  FDA 510(k) K854756 Active Cleared 15 May 1986

• Min-Molecule Pth by Radioimmunoassay

  Class II

  FDA 510(k) K820228 Active Cleared 11 Mar 1982

• Orchard Grass Allergen Disc

  Class II

  FDA 510(k) K862939 Active Cleared 15 Aug 1986

• Acth Radioimmunoassay Kit

  Class II

  FDA 510(k) K811565 Active Cleared 25 Jun 1981

• Meadow Fescue Allergen Disc

  Class II

  FDA 510(k) K863098 Active Cleared 15 Sep 1986

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• What is the Cyclic AMP Radioimmunoassay Kit used for?

  This kit is designed for in vitro diagnostic use to measure adenosine 3′,5′-monophosphate (cyclic AMP) levels in biological samples such as plasma, urine, and other body fluids. It aids in diagnosing endocrine disorders, including hyperparathyroidism, by quantifying hormone-related signaling molecules through radiolabelled immunoassay techniques.

• How is the Cyclic AMP Radioimmunoassay Kit supplied?

  The kit is supplied as a radioimmunoassay system, requiring proper handling of radioactive materials. It is intended for laboratory use and is classified under the FDA’s Clinical Chemistry product code (CHO). No specific details on sterility, single-use, or storage conditions are provided in the available data.

• Is the Cyclic AMP Radioimmunoassay Kit single-use or reusable?

  The available data does not specify whether the kit is single-use or reusable. However, as a radioimmunoassay system, it likely requires careful handling and may not be designed for repeated use due to the nature of radioactive materials involved.

• What regulatory approval does the Cyclic AMP Radioimmunoassay Kit hold?

  The kit holds a traditional 510(k) clearance (K823504) from the FDA, filed under the Clinical Chemistry advisory committee (CH) in 1982 and cleared in 1983. It is classified under the FDA’s product code CHO and falls under Class II regulatory classification (862.1230).

• What types of biological samples can be tested with this kit?

  The kit is specifically designed to measure cyclic AMP levels in plasma, urine, and other body fluids. It uses radiolabelled immunoassay techniques to provide precise detection and quantification of cyclic AMP concentrations in these samples.