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510(k) K191021

Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye by Terragene S.A. — Product Code FRC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 2019
Date Received
April 17, 2019
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 S.A.

  • K251122 — Terragene® Bionova® BT20 Biological Indicator (August 4, 2025)
  • K242453 — Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (December 12, 2024)
  • K231383 — Terragene® Bionova® Self-Contained Biological Indicator (BT95), Terragene® Biono (September 18, 2024)
  • 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)
  • K163646 — Terragene Bionova(R) SCBI (BT220, BT221, BT222, BT223), Terragene Bionova (R) PC (November 2, 2017)

Other clearances for product code FRC

  • K252680 — Celerity™ 20 HP Biological Indicator (September 24, 2025)
  • K251122 — Terragene® Bionova® BT20 Biological Indicator (August 4, 2025)
  • K251452 — Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB05 (June 6, 2025)
  • K250044 — Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB05 (February 6, 2025)
  • K250061 — Celerity Incubator (February 6, 2025)
  • K243501 — 3M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE; 3M™ (January 28, 2025)
  • K242453 — Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (December 12, 2024)
  • 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)