Terragene Bionava SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)— 510(k) K223023
Substantially EquivalentPlasmapp Co,., Ltd.
FDA 510(k) clearance K223023 for Terragene Bionava SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40), Substantially Equivalent on 2023-05-09. Applicant: Plasmapp Co,., Ltd.. Device class: 2.
Clearance details
- Applicant
- Plasmapp Co,., Ltd.
- Product code
- Code FRC
- Device class
- Class 2
- Regulation
- 21 CFR 880.2800
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Daejeon, KR
Recent devices under product code FRC
view allMore clearances from Plasmapp Co,., Ltd.
view all- 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)
- K223015 — STERLINK FPS-15s Plus sterilizer with STERPACK plus cassette
- K223025 — Tyvek Roll with CI for STERLINK Sterilizer
- K220345 — STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Sterilization Process Indicator for STERLINK Sterilizer +1 more
- K212193 — Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)
Data sourced from openFDA. This site is unofficial and independent of the FDA.