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510(k) K251122

Terragene® Bionova® BT20 Biological Indicator by Terragene — Product Code FRC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 2025
Date Received
April 11, 2025
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 Terragene

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  • DEN220042 — Terragene Bionova Photon Biological Indicator (BT225); Terragene Bionova Photon (July 12, 2024)
  • K232103 — Terragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene® Chemdye® (April 5, 2024)
  • K221641 — Terragene® Bionova® Hyper Biological Indicator (BT98), Terragene® Bionova® Hyper (February 28, 2023)
  • K200272 — Terragene Chemdye (June 30, 2020)
  • K191021 — Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Ter (September 13, 2019)
  • K163646 — Terragene Bionova(R) SCBI (BT220, BT221, BT222, BT223), Terragene Bionova (R) PC (November 2, 2017)

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  • K242538 — 3M™ Attest™ Super Rapid Readout Biological Indicator 1493; 3M™ Attest™ Super Rap (November 25, 2024)
  • K241959 — 3M™ Attest™ Super Rapid Steam Clear Challenge Pack (1492PCD); 3M™ Attest™ Auto-r (October 18, 2024)
  • K231383 — Terragene® Bionova® Self-Contained Biological Indicator (BT95), Terragene® Biono (September 18, 2024)
  • K241710 — 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V; 3M™ Attest™ Auto-rea (September 12, 2024)