Elvi Biclot 816

No FDA recalls on record, checked 11 Oct 2026.

510(k) Number

K812906 ↗

FDA Product Code

KQG

Device Class

Class II

Regulation

21 CFR Part 864.5400

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Agglutinotest-Thyroglobulin

  Class II

  FDA 510(k) K791458 Active Cleared 31 Dec 1979

• Volu-Sol Nmb Reticulocyte Stain

  Class I

  FDA 510(k) K792496 Active Cleared 31 Dec 1979

• Volu-Sol Gills Ea

  Class I

  FDA 510(k) K822035 Active Cleared 3 Aug 1982

• Elvi Inorganic Phosphorous

  Class I

  FDA 510(k) K792401 Active Cleared 7 Dec 1979

• Volu-Sol Bovins Fixative

  Class I

  FDA 510(k) K822129 Active Cleared 5 Aug 1982

• Agglutinotest-Rheumatoid Arthritis

  Class II

  FDA 510(k) K791507 Active Cleared 31 Dec 1979

See all devices from Volu Sol Medical Industries →