Plasmapp Co., Ltd.
Asan-si Chungnam, KR
Plasmapp Co., Ltd. appears in FDA device records in Asan-si Chungnam, KR. FDA records list 8 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 8 510(k) clearances for Plasmapp Co., Ltd. between 2021 and 2023. The busiest year on record is 2023, with 5. The most recent is 2023, with 5.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2021 | 3 |
| 2023 | 5 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| 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) | MLR | Substantially Equivalent | |
| K223025 | Tyvek Roll with CI for STERLINK Sterilizer | FRG | Substantially Equivalent | |
| K223023 | Terragene Bionava SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) | FRC | Substantially Equivalent | |
| K223015 | STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette | MLR | Substantially Equivalent | |
| K220345 | STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Sterilization Process Indicator for STERLINK Sterilizer; Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-Bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) | MLR | Substantially Equivalent | |
| K212200 | STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette | MLR | Substantially Equivalent | |
| K212198 | Tyvek(R) Roll with CI for STERLINKTM Sterilizer | FRG | Substantially Equivalent | |
| K212193 | Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) | FRC | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3016075971 | 3016075971 | Plasmapp Co., Ltd. | A-1005, 10F, 670, Daewangpangyo-ro, Bundang-gu, Seongnam-si Gyeonggi 13494 KR | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain