K231169 is an FDA 510(k) clearance for the 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). This device is classified as a Sterilizer, Chemical (Class II - Special Controls, product code MLR).
Submitted by Plasmapp Co,., Ltd. (Daejeon, KR). The FDA issued a Cleared decision on May 25, 2023, 30 days after receiving the submission on April 25, 2023.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6860.
| 510(k) Number | K231169 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 25, 2023 |
| Decision Date | May 25, 2023 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | MLR - Sterilizer, Chemical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6860 |