Iga, Fitc, Antigen, Antiserum, Control

FDA product code CZN · Class II (moderate risk) · 21 CFR 866.5510 · Immunology

7510(k) clearances
0PMA approvals
0recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K891683Titan Gel Ife Free Kappa/Lamba Light Chain AntiserCZN · Traditional Helena Laboratories04/12/1989SE
K855011Quantimetric Plus C3 Reagent KitCZN · Traditional Kallestad Laboratories, Inc.02/26/1986SE
K841815Optimate Iga TestCZN · Traditional Miles Laboratories, Inc.06/01/1984SE
K832262Fitc Goat Anti-Human ImmunoglobulinsCZN · Traditional Gelco Diagnostics, Inc.10/31/1983SE
K832257Goat Anti-Human Iga a Chain SpecificCZN · Traditional Gelco Diagnostics, Inc.10/28/1983SE
K831909Rabbit Antiserum to Human IgaCZN · Traditional Dako Corp.07/18/1983SE
K831607Fiax Iga Test KitCZN · Traditional Intl. Diagnostic Technology06/22/1983SE