510(k) K203284
- Device
- 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator
- Applicant
- 3M Company
- 510(k) number
- K203284
- Product code
- QKM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-12-07
- Date received
- 2020-11-09
- Regulation
- 880.2800
- Classification name
- A Chemical Vapor Sterilization Multivariable Chemical Indicator
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- Andrew Wingen
- Address
- 2510 Conway Ave., Bldg. 275-5w-06 St. Paul MN US 55144 55144
FDA Registration Numbers
- 3004080920
- 8021896
- 3013145340
- 3031841433
- 3031757047
- 3000251274
- 3015392401
- 3042272797
Source Documents
Other 510(k) Records For Product Code QKM
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K212022 | 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E | 3M Company | 2022-04-20 |
| K213262 | CELERITY HP Chemical Indicator | STERIS Corporation | 2022-01-07 |
| K193110 | 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E | 3M Healthcare | 2020-03-13 |