Bactec Mgit 960 System

• • Terminated Z-0028-2014 FDA Class II ·initiated 9 Sep 2013

  An in-vitro diagnostic reagent may be labeled with an incorrect barcode, which when scanned on associated diagnostic instrument may cause a false negative result.

• • Terminated Z-2890-2011 FDA Unclassified (pre-2012) ·initiated 28 Mar 2011

  Software contained three additional set configurations which caused the system to reinitialized the AST set carrier defaults.

510(k) Number

K974883 ↗

FDA Product Code

MDB

Device Class

Class I

Regulation

21 CFR Part 866.2560

Advisory Committee

Microbiology

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 →