The following data is part of a premarket notification filed by Steris Corporations with the FDA for Verify V24 Self-contained Biological Indicator, Verify V24 Biological Indicator Challenge Pack.
| Device ID | K183300 |
| 510k Number | K183300 |
| Device Name: | VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack |
| Classification | Indicator, Biological Sterilization Process |
| Applicant | STERIS Corporations 5960 Heisley Road Mentor, OH 44060 |
| Contact | Gregory Land |
| Correspondent | Gregory Land STERIS Corporations 5960 Heisley Road Mentor, OH 44060 |
| Product Code | FRC |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-27 |
| Decision Date | 2019-01-03 |
| Summary: | summary |