DEN230068 is an FDA 510(k) submission for the 3M™ Attest™ eBowie-Dick Test Card 10135 3M™ Attest™ eBowie-Dick Card Holder 10135CH 3M™ Attest™ eBowie-Dick Auto-reader 1190. This device is classified as a Indicator, Physical/chemical Sterilization Process (Class II - Special Controls, product code JOJ).
Submitted by 3M Company (St. Paul, US). The FDA issued a Not Cleared (DENG) decision on May 21, 2024.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2800.
| 510(k) Number | DEN230068 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | September 29, 2023 |
| Decision Date | May 21, 2024 |
| Days to Decision | 235 days |
| Submission Type | Direct |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | JOJ — Indicator, Physical/chemical Sterilization Process |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.2800 |