Aso Slide Eiken

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K853276 ↗

FDA Product Code

GTQ

Device Class

Class I

Regulation

21 CFR Part 866.3720

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Blf Eiken Kit Deter. of B-Lipopr. Frac.

  Class I

  FDA 510(k) K802451 Active Cleared 9 Jan 1981

• Got Isoenzyme Assay Eiken Kit

  Class II

  FDA 510(k) K802447 Active Cleared 17 Apr 1981

• Ra 80 Eiken Kit Determ. of Rheumatic F.

  Class II

  FDA 510(k) K802448 Active Cleared 5 Jan 1981

• Fibrogen(Fibrin Split Product) Antigen

  Class II

  FDA 510(k) K812298 Active Cleared 17 Dec 1981

• Uropaper Eiken Uhag

  Class II

  FDA 510(k) K811816 Active Cleared 8 Dec 1981

• Uropaper Eiken 5

  Class II

  FDA 510(k) K843756 Active Cleared 18 Dec 1984

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