The following data is part of a premarket notification filed by 3m Company with the FDA for 3m Attest Rapid Readout Biological Indicator 1295.
| Device ID | K152060 |
| 510k Number | K152060 |
| Device Name: | 3M Attest Rapid Readout Biological Indicator 1295 |
| Classification | Indicator, Biological Sterilization Process |
| Applicant | 3M COMPANY 3M CENTER, BUILDING 275-5W-06 St. Paul, MN 55144 |
| Contact | Matt Mortensen |
| Correspondent | Matt Mortensen 3M COMPANY 3M CENTER, BUILDING 275-5W-06 St. Paul, MN 55144 |
| Product Code | FRC |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-24 |
| Decision Date | 2015-12-01 |
| Summary: | summary |