The following data is part of a premarket notification filed by Steris Corporation with the FDA for Browne Opa Test Strip.
| Device ID | K081427 |
| 510k Number | K081427 |
| Device Name: | BROWNE OPA TEST STRIP |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | STERIS Corporation 5960 Heisley Road Mentor, OH 44060 |
| Contact | Robert Sullivan |
| Correspondent | Robert Sullivan STERIS Corporation 5960 Heisley Road Mentor, OH 44060 |
| Product Code | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-21 |
| Decision Date | 2008-06-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30705037045567 | K081427 | 000 |
| 30705037045550 | K081427 | 000 |