B.E.C. Growth Chek Microbial Suspensions

• • Terminated Z-1043-2009 FDA Unclassified (pre-2012) ·initiated 13 Jan 2009 ·on shared 510(k) K842579

  Candida albicans microbial suspension, certified to deliver less than 100 organisms per dose, was found to have a population count which exceeded 100 organisms per dose, following distribution.

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

510(k) Number

K842579 ↗

FDA Product Code

JTR

Device Class

Class I

Regulation

21 CFR Part 866.2480

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

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• Updated Sterile Gowns, Masks and Towels

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  Class II

  FDA 510(k) K961328 Active Cleared 30 May 1996

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