Bact/Alert Sn

• • Terminated Z-0749-2016 FDA Class II ·initiated 24 Dec 2015

  Bottles may have been exposed to non-normal shipping conditions which may lead to media degradation and impact growth performance.

510(k) Number

K993421 ↗

FDA Product Code

MDB

Device Class

Class I

Regulation

21 CFR Part 866.2560

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Fibrinostika Tdp Microelisa System

  Class II

  FDA 510(k) K915698 Active Cleared 5 Aug 1992

• Nephross I.Q. Andante

  Class II

  FDA 510(k) K874549 Active Cleared 29 Jan 1988

• Mda Protein Assay

  Class II

  FDA 510(k) K925617 Active Cleared 27 Jan 1994

• Bsm 2000 Dialysis Machine

  Class II

  FDA 510(k) K840062 Active Cleared 22 Mar 1984

• Bact/Alert Culture Bottles

  Class I

  FDA 510(k) K973305 Active Cleared 17 Nov 1997

• Nuclisens Cmv PP67

  Class II

  FDA 510(k) K983762 Active Cleared 15 Sep 1999

See all devices from Organon Teknika Corp. →