The following data is part of a premarket notification filed by Advanced Sterilization Products (asp) with the FDA for Sterrad Velocity Biological Indicator/process Challenge Device And Reader.
| Device ID | K192025 |
| 510k Number | K192025 |
| Device Name: | STERRAD VELOCITY Biological Indicator/Process Challenge Device And Reader |
| Classification | Indicator, Biological Sterilization Process |
| Applicant | Advanced Sterilization Products (ASP) 33 Technology Drive Irvine, CA 92618 |
| Contact | Elsie Kim |
| Correspondent | Elsie Kim Advanced Sterilization Products (ASP) 33 Technology Drive Irvine, CA 92618 |
| Product Code | FRC |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-29 |
| Decision Date | 2020-01-23 |
| Summary: | summary |