Submission Details
| 510(k) Number | K203284 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 09, 2020 |
| Decision Date | December 07, 2020 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Special
3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator
Dec 2020
Decision
28d
Days
Class 2
Risk
About This 510(k) Submission
K203284 is an FDA 510(k) clearance for the 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator, a A Chemical Vapor Sterilization Multivariable Chemical Indicator (Class II — Special Controls, product code QKM), submitted by 3M Company (Saint Paul, US). The FDA issued a Cleared decision on December 7, 2020, 28 days after receiving the submission on November 9, 2020. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2800.
Device Classification
| Product Code | QKM — A Chemical Vapor Sterilization Multivariable Chemical Indicator |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.2800 |
| Definition | A Chemical Vapor Sterilization Multivariable Chemical Indicator Monitors Two Or More Parameters Of A Chemical Vapor Sterilization Process. |
Manufacturer
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