The following data is part of a premarket notification filed by Crosstex International with the FDA for Sporview Plus Bi Test Pack.
| Device ID | K140620 |
| 510k Number | K140620 |
| Device Name: | SPORVIEW PLUS BI TEST PACK |
| Classification | Indicator, Biological Sterilization Process |
| Applicant | CROSSTEX INTERNATIONAL 6789 WEST HENRIETTA ROAD Rush, NY 14543 |
| Contact | Michael G Nolan |
| Correspondent | Michael G Nolan CROSSTEX INTERNATIONAL 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 | 2014-03-11 |
| Decision Date | 2014-08-07 |
| Summary: | summary |