The following data is part of a premarket notification filed by Steris Corporation with the FDA for Verify Assert Self-contained Biological Indicator.
| Device ID | K200126 |
| 510k Number | K200126 |
| Device Name: | VERIFY Assert Self-Contained Biological Indicator |
| Classification | Indicator, Biological Sterilization Process |
| Applicant | STERIS Corporation 5960 Heisley Road Mentor, OH 44060 |
| Contact | Anthony Piotrkowski |
| Correspondent | Anthony Piotrkowski STERIS Corporation 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 | 2020-01-21 |
| Decision Date | 2020-05-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10724995153035 | K200126 | 000 |
| 10724995153028 | K200126 | 000 |
| 10724995153011 | K200126 | 000 |