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510(k) K231169

STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) by Plasmapp Co,., Ltd. — Product Code MLR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 25, 2023
Date Received
April 25, 2023
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilizer, Chemical
Device Class
Class II
Regulation Number
880.6860
Review Panel
HO
Submission Type

Other clearances by Plasmapp Co,., Ltd.

  • K223025 — Tyvek Roll with CI for STERLINK Sterilizer (May 9, 2023)
  • K223015 — STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette (May 9, 2023)
  • K223023 — Terragene Bionava SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD (May 9, 2023)
  • K220345 — STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STE (April 14, 2023)
  • K212198 — Tyvek(R) Roll with CI for STERLINKTM Sterilizer (October 22, 2021)
  • K212193 — Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD (October 22, 2021)
  • K212200 — STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette (October 22, 2021)

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  • K233762 — SteroScope® Sterilization Technology System (June 27, 2024)
  • K233065 — V-PRO maX 2 Low Temperature Sterilization System (October 20, 2023)
  • K223476 — V-PRO maX 2 Low Temperature Sterilization System (August 7, 2023)
  • K223015 — STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette (May 9, 2023)
  • K220345 — STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STE (April 14, 2023)
  • K222093 — V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Ster (September 9, 2022)
  • K220404 — STERRAD NX with ALLClear Technology (May 16, 2022)