Premier C. Difficile, Modification

• • Terminated Z-0463-03 FDA Unclassified (pre-2012) ·initiated 26 Dec 2002 ·on shared 510(k) K926442

  Due to defective packaging, the firm cannot assure product stability through the labeled expiration date.

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

510(k) Number

K926442 ↗

FDA Product Code

LLH

Device Class

Class I

Regulation

21 CFR Part 866.2660

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Blastomyces Dermatitidis Antigen (JWW)

  Class II

  FDA 510(k) K792680 Active Cleared 17 Jan 1980

• Candida Albicans, Antiserum

  Class II

  FDA 510(k) K792713 Active Cleared 23 Jan 1980

• Lacto-Phenol Analine Blue Fluid

  Class I

  FDA 510(k) K792703 Active Cleared 24 Jan 1980

• Immunocard Mycoplasma

  Class I

  FDA 510(k) K934550 Active Cleared 20 Sep 1994

• Histoplasma Capsulatum, Antiserum

  Class II

  FDA 510(k) K792718 Active Cleared 17 Jan 1980

• Blastomyces Dermatitidis, Antiserum

  Class II

  FDA 510(k) K792685 Active Cleared 17 Jan 1980

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