The following data is part of a premarket notification filed by Steris Corporation with the FDA for Celerity Hp Chemical Indicator.
| Device ID | K213262 |
| 510k Number | K213262 |
| Device Name: | CELERITY HP Chemical Indicator |
| Classification | A Chemical Vapor Sterilization Multivariable Chemical Indicator |
| Applicant | Steris Corporation 5960 Heisley Rd Mentor, OH 44060 |
| Contact | Anthony Piotrkowski |
| Correspondent | Anthony Piotrkowski Steris Corporation 5960 Heisley Rd Mentor, OH 44060 |
| Product Code | QKM |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-30 |
| Decision Date | 2022-01-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50724995218589 | K213262 | 000 |