Spottest Lactophenol Cotton Blue Stain

• • Terminated Z-0978-2010 FDA Unclassified (pre-2012) ·initiated 28 Sep 2009

  An in-vitro diagnostic reagent used by clinical laboratories was mislabeled.

510(k) Number

K842086 ↗

FDA Product Code

JTO

Device Class

Class I

Regulation

21 CFR Part 866.2660

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Differentiation Disks Vancomycin 5 Mcg

  Class I

  FDA 510(k) K860563 Active Cleared 11 Mar 1986

• Dispens-O-Disc(Tm) Nitrocefin

  Class I

  FDA 510(k) K941016 Active Cleared 30 Jun 1994

• Differentiation Disks Bile Esculin

  Class I

  FDA 510(k) K843364 Active Cleared 7 Sep 1984

• Spottest Voges-Proskauer Reagent a

  Class I

  FDA 510(k) K840578 Active Cleared 27 Feb 1984

• Toxo-Cube

  Class II

  FDA 510(k) K903968 Active Cleared 18 Dec 1990

• Broth Elution Disks Clindamycin 10mcg

  Class II

  FDA 510(k) K870175 Active Cleared 29 Apr 1987

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