Affinity(Tm) System

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K865105 ↗

FDA Product Code

JJE

Device Class

Class I

Regulation

21 CFR Part 862.2160

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Leuco Prep

  Class I

  FDA 510(k) K854093 Active Cleared 12 Nov 1985

• Qbc System Hemoglobin

  Class II

  FDA 510(k) K874427 Active Cleared 5 Jan 1988

• Sensicare Synthetic Medical Gloves

  Class I

  FDA 510(k) K915478 Active Cleared 27 Jan 1992

• Qbc Centrifugal Hematology Analyzer

  Class II

  FDA 510(k) K844645 Active Cleared 5 Mar 1985

• Holesterol Delta Test Assay

  Class I

  FDA 510(k) K771582 Active Cleared 13 Sep 1977

• Delta Test Triglycerides

  Class I

  FDA 510(k) K802136 Active Cleared 10 Oct 1980

See all devices from Bd Becton Dickinson Vacutainer Systems Preanalytic →