Gelman Ig-Fix Kit

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

510(k) Number

K812253 ↗

FDA Product Code

CZP

Device Class

Class II

Regulation

21 CFR Part 866.5510

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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  Class I

  FDA 510(k) K850260 Active Cleared 27 Feb 1985

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  Class II

  FDA 510(k) K884177 Active Cleared 17 Feb 1989

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  FDA 510(k) K943127 Active Cleared 29 Sep 1994

• Electrophoresis Reagent Set, Hdl

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  FDA 510(k) K790791 Active Cleared 15 Jun 1979

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  FDA 510(k) K821303 Active Cleared 12 May 1982

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  FDA 510(k) K810047 Active Cleared 5 Feb 1981

See all devices from Gelman Sciences, Inc. →

• What is the purpose of the Gelman Ig-Fix Kit?

  The Gelman Ig-Fix Kit is a diagnostic immunology device used for fixation and analysis of immunoglobulins, antigens, and antisera in clinical testing. It prepares samples for immunoelectrophoresis and related immunoassays by immobilizing proteins in agarose gels.

• How is the Gelman Ig-Fix Kit supplied?

  The kit is supplied as a single-use diagnostic reagent intended for laboratory settings. It includes components for immunoelectrophoresis and follows standard immunology laboratory practices.

• What is the regulatory classification of the Gelman Ig-Fix Kit?

  The kit is classified under FDA regulation 866.5510 and has received Traditional 510(k) clearance (K812253) as substantially equivalent to a predicate device.

• What types of samples can be analyzed using the Gelman Ig-Fix Kit?

  The kit is designed for the fixation and analysis of immunoglobulins, antigens, and antisera in clinical testing, facilitating precise identification and quantification through immunoelectrophoresis.