Fungal Immunodiffusion System

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

510(k) Number

K812185 ↗

FDA Product Code

GMI

Device Class

Class II

Regulation

21 CFR Part 866.3135

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Streptacoccus Co-Agglutination Kit

  Class I

  FDA 510(k) K822799 Active Cleared 19 Dec 1982

• Dispo Fibrin Pipet Tips B4182-2

  Class II

  FDA 510(k) K820532 Active Cleared 8 Apr 1982

• Infectious Tissue Kit

  Not classified

  FDA 510(k) K864824 Active Cleared 24 Dec 1986

• Vaspar Sealent

  Class I

  FDA 510(k) K812191 Active Cleared 31 Aug 1981

• Smith's Systemic Fungal Medium

  Class I

  FDA 510(k) K812187 Active Cleared 31 Aug 1981

• Staphylococcus Latex Agglutination Kit

  Class I

  FDA 510(k) K820683 Active Cleared 14 Apr 1982

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• What is the primary clinical purpose of the Fungal Immunodiffusion System?

  This system is designed for the evaluation of suspected mycoses. It functions as an antigen, complement fixation, and immunodiffusion device to provide specificity data on reactions and allows for the testing of anti-complementary sera.

• Under what regulatory classification is this device categorized?

  The Fungal Immunodiffusion System is regulated under 21 CFR 866.3135 and is classified as a Class 2 medical device. It received FDA 510(k) clearance under number K812185 on August 25, 1981.

• What product code is associated with this immunodiffusion device?

  The device is identified by product code GMI, which falls under the Microbiology advisory committee for regulatory tracking purposes.