The following data is part of a premarket notification filed by Steris Corporation with the FDA for Verify Spore Test Strip For S40 Sterilant.
| Device ID | K180553 |
| 510k Number | K180553 |
| Device Name: | VERIFY Spore Test Strip For S40 Sterilant |
| Classification | Liquid Chemical Processing System |
| Applicant | Steris Corporation 5960 Heisley Road Mentor, OH 44060 |
| Contact | Marcia L. Benedict |
| Correspondent | Marcia L. Benedict Steris Corporation 5960 Heisley Road Mentor, OH 44060 |
| Product Code | OVY |
| CFR Regulation Number | 880.6887 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-01 |
| Decision Date | 2018-05-29 |
| Summary: | summary |