Prospore

• 2 recalls, same reason

  • Terminated Z-1274-2018 FDA Class II ·initiated 12 Feb 2018
  • Terminated Z-1273-2018 FDA Class II ·initiated 12 Feb 2018

  The concentration of bromocresol purple in the recalled lots does not conform to specification.

• • Terminated Z-1104-2017 FDA Class II ·initiated 4 Apr 2016

  Product resistance has fallen outside of label claim within expiry.

510(k) Number

K971432 ↗

FDA Product Code

FRC

Device Class

Class II

Regulation

21 CFR Part 880.2800

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Pro-Pact Peracetic Acid Culture Test Kit, Model C-3PA

  Class II

  FDA 510(k) K031114 Active Cleared 3 Mar 2004

• Raven Propact

  Class II

  FDA 510(k) K053212 Active Cleared 15 Feb 2006

• Modification to:raven Bacterial Spore Strips Open recall

  Class II

  FDA 510(k) K032914 Active Cleared 25 May 2004

• Prospore II

  Class II

  FDA 510(k) K960790 Active Cleared 16 Aug 1996

• Raven Protest - Steam Biological Indicator

  Class II

  FDA 510(k) K082756 Active Cleared 21 Oct 2009

• Modification to Raven Bacterial Spore Strips Open recall

  Class II

  FDA 510(k) K050591 Active Cleared 23 Mar 2005

See all devices from Raven Biological Laboratories, Inc. →