Bact/Alert Fn

• • Terminated Z-1189-2007 FDA Unclassified (pre-2012) ·initiated 16 Feb 2007 ·on shared 510(k) K992432

  Microbial Contamination: Bacillus sp. contamination was detected in inoculated bottles.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K992432 ↗

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

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