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510(k) K053212

RAVEN PROPACT by Raven Biological Laboratories, Inc. — Product Code MRB

K053212 is an FDA 510(k) premarket notification submitted by Raven Biological Laboratories, Inc. for the device "RAVEN PROPACT". The FDA issued a decision of Substantially Equivalent on February 15, 2006. The device falls under product code MRB (Indicator, Biological, Liquid Chemical Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Raven Biological Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 15, 2006
Date Received
November 16, 2005
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Indicator, Biological, Liquid Chemical Sterilization Process
Device Class
Class II
Regulation Number
880.2800
Review Panel
HO
Submission Type

Other clearances by Raven Biological Laboratories, Inc.

  • K082756 — RAVEN PROTEST - STEAM BIOLOGICAL INDICATOR (October 21, 2009)
  • K062651 — PROCHEM EXT CHEMICAL INTEGRATOR (March 15, 2007)
  • K050591 — MODIFICATION TO RAVEN BACTERIAL SPORE STRIPS (March 23, 2005)
  • K041784 — RAVEN PROTEST - EO (September 13, 2004)
  • K041386 — RAVEN PROTEST - STEAM (August 9, 2004)
  • K032914 — MODIFICATION TO:RAVEN BACTERIAL SPORE STRIPS (May 25, 2004)
  • K031114 — PRO-PACT PERACETIC ACID CULTURE TEST KIT, MODEL C-3PA (March 3, 2004)
  • K020026 — RAVEN BACTERIAL SPORE STRIPS (January 30, 2002)
  • K994381 — PROSPORE2 SELF-CONTAINED BIOLOGICAL INDICATOR (March 30, 2001)
  • K971430 — PROSPORE II (May 22, 1997)

Other clearances for product code MRB

  • K081879 — SPSMEDICAL SPORVIEW PA CULTURE SET (July 30, 2008)
  • K043135 — SPSMEDICAL SPORVIEW PA CULTURE SET (January 13, 2005)
  • K031114 — PRO-PACT PERACETIC ACID CULTURE TEST KIT, MODEL C-3PA (March 3, 2004)

FDA data resources