Kappa Serum (Free) Anti-Human

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

510(k) Number

K781027 ↗

FDA Product Code

DFH

Device Class

Class II

Regulation

21 CFR Part 866.5550

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K820879 Active Cleared 16 Apr 1982

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  FDA 510(k) K781026 Active Cleared 10 Aug 1978

• Ceruoplasmin Serum Anti-Human

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  FDA 510(k) K832823 Active Cleared 14 Oct 1983

• Kova Trol III

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  FDA 510(k) K780482 Active Cleared 3 May 1978

See all devices from Icl Scientific →

• What is Kappa Serum (Free) Anti-Human used for?

  Kappa Serum (Free) Anti-Human is an immunology device classified as an antigen, antiserum, or control. It is used in laboratory settings for detecting or measuring kappa light chains in human samples, serving as a reagent in immunoassays where specific binding to human kappa immunoglobulins is required.

• How is Kappa Serum (Free) Anti-Human supplied and is it sterile or single-use?

  The device data does not specify the supply format, sterility, or single-use/reuse status of Kappa Serum (Free) Anti-Human. As an immunology antigen or antiserum control, it is typically provided in liquid form in vials for in vitro diagnostic use, but users should consult the manufacturer's labeling for exact preparation, storage, and handling instructions.

• What regulatory clearance does Kappa Serum (Free) Anti-Human have?

  Kappa Serum (Free) Anti-Human received traditional 510(k) clearance from the FDA under K number K781027. It was determined to be substantially equivalent to a predicate device, with a decision date of July 27, 1978, and is classified under product code DFH and regulation number 866.5550.