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510(k) K113221

NAMSA BIOLOGICAL INDICATOR SPORE STRIPS by North American Science Assoc., Inc. — Product Code FRC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 2012
Date Received
November 1, 2011
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 North American Science Assoc., Inc.

  • K141244 — NAMSA BIOLOGICAL INDICATOR SPORE STRIPS (DUAL SPECIES) NAMSA BIOLOGICAL INDICATO (September 9, 2014)
  • K132291 — NAMSA CHEMICAL PROCESS (May 20, 2014)
  • K113302 — NAMSA STEAM SELF-CONTAINED BIOLOGICAL INDICATORS (January 20, 2012)
  • K983451 — CHALLENGE TEST PACK (April 23, 1999)
  • K962649 — SPORTROL RAPID STERILITY INDICATOR (September 26, 1997)

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