The following data is part of a premarket notification filed by Crosstex/spsmedical, A Division Of Cantel Medical with the FDA for Sporview Rapid Read Biological Indicator Steamplus Test Pack.
| Device ID | K181434 |
| 510k Number | K181434 |
| Device Name: | SporView Rapid Read Biological Indicator SteamPlus Test Pack |
| Classification | Indicator, Biological Sterilization Process |
| Applicant | Crosstex/SPSmedical, A Division Of Cantel Medical 6789 West Henrietta Road Rush, NY 14543 |
| Contact | Megan Skaar |
| Correspondent | Megan Skaar Crosstex/SPSmedical, A Division Of Cantel Medical 6789 West Henrietta Road Rush, NY 14543 |
| Product Code | FRC |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-01 |
| Decision Date | 2018-11-14 |
| Summary: | summary |