FDA Product Code
FDA Product Code QKM — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.2800
510(k) Clearances — 5 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K232103 | Terragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40) | Terragene S.A. | 2024-04-05 | Traditional | PDF ↗ |
| K212022 | 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E | 3M Company | 2022-04-20 | Traditional | PDF ↗ |
| K213262 | CELERITY HP Chemical Indicator | STERIS Corporation | 2022-01-07 | Traditional | PDF ↗ |
| K203284 | 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator | 3M Company | 2020-12-07 | Special | PDF ↗ |
| K193110 | 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E | 3M Healthcare | 2020-03-13 | Traditional | PDF ↗ |
Product code QKM · Class II · General Hospital. Data: openFDA.