Radioimmunoassay Immunoglobulins D.E

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

510(k) Number

K830357 ↗

FDA Product Code

DGC

Device Class

Class II

Regulation

21 CFR Part 866.5510

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Hcg Beta Ria Kit

  Class II

  FDA 510(k) K822152 Active Cleared 2 Sep 1982

• Tsh Receptor Antibody Kit 125I Tsh

  Class II

  FDA 510(k) K841580 Active Cleared 22 Oct 1984

• Adrenocorticotropic Hormone Test

  Class II

  FDA 510(k) K833934 Active Cleared 4 Apr 1984

• 125-I Fsh Radioimmunoassay Kit

  Class I

  FDA 510(k) K823379 Active Cleared 22 Dec 1982

• 125-I Lh Radioimmunoassay Kit

  Class I

  FDA 510(k) K823380 Active Cleared 22 Dec 1982

• Clinetics Pca Column

  Class II

  FDA 510(k) K801306 Active Cleared 26 Sep 1980

See all devices from Clinetics Corp. →

• What is the Radioimmunoassay Immunoglobulins D.E used for?

  The Radioimmunoassay Immunoglobulins D.E is used for the detection and quantification of immunoglobulins D and E in clinical laboratory settings via radioimmunoassay methodology, serving as an in vitro diagnostic tool for immunological analysis.

• How is the Radioimmunoassay Immunoglobulins D.E supplied and what is its regulatory status?

  The device is supplied as a diagnostic reagent system and is regulated under FDA 510(k) clearance K830357, with product code DGC and regulation number 866.5510, indicating it is a Class II medical device substantially equivalent to a predicate device.

• Is the Radioimmunoassay Immunoglobulins D.E sterile, single-use, or reusable?

  The provided data does not describe the Radioimmunoassay Immunoglobulins D.E as sterile, single-use, or reusable; therefore, no claims about sterility or reusability can be made based on the available information.