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510(k) K923739

ABTOX SERILIZATION PROCESS BIOLOGICAL INDICATOR by Abtox, Inc. — Product Code FRC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1994
Date Received
July 27, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Abtox, Inc.

  • K905119 — PLAZLYTE(TM) (December 22, 1994)
  • K923442 — ABTOX PLAZLYTE PROCESS MONITOR (December 22, 1994)

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