PROSPORE2 Self-Contained Biological Indicator

• • Terminated Z-0205-06 FDA Unclassified (pre-2012) ·initiated 18 Mar 2005

  The certified Ethylene Oxide D-values of the lots cannot be confirmed to be within specification.

510(k) Number

K994381 ↗

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. →