Fitc Goat Anti-Human Kappa Affinity

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

510(k) Number

K832266 ↗

FDA Product Code

DFH

Device Class

Class II

Regulation

21 CFR Part 866.5550

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Goat Anti-Human Kappa Affinity

  Class II

  FDA 510(k) K832260 Active Cleared 31 Oct 1983

• Goat Anti-Human Lamba

  Class II

  FDA 510(k) K832270 Active Cleared 31 Oct 1983

• Goat Anti-Human Immunoglobulins-

  Class II

  FDA 510(k) K832256 Active Cleared 31 Oct 1983

• Fitc Goat Anti-Human Iga a Chain

  Class II

  FDA 510(k) K832263 Active Cleared 31 Oct 1983

• Goat Anti-Human Igm H Chain

  Class II

  FDA 510(k) K832259 Active Cleared 28 Oct 1983

• Goat Anti-Human Lamba Affinity

  Class II

  FDA 510(k) K832261 Active Cleared 28 Oct 1983

See all devices from Gelco Diagnostics, Inc. →

• What is the Fitc Goat Anti-Human Kappa Affinity used for?

  The device is used to detect or measure kappa antigens in human samples, specifically in immunology applications.

• How is the device supplied?

  The device is supplied by Gelco Diagnostics, Inc. and is intended for use in immunology applications, stored and handled according to standard procedures for antibodies and other immunological reagents.

• Is the device sterile?

  The description does not explicitly state the device's sterility, but it is regulated under 21 CFR 866.5550 and has a 510(k) clearance, indicating it meets certain standards for safety and effectiveness.

• What is the regulatory classification of the device?

  The device is classified as a class 2 device, regulated under 21 CFR 866.5550, and has been cleared by the FDA with a 510(k) number of K832266.