The following data is part of a premarket notification filed by Unipath Ltd. with the FDA for Staphytect-od.
| Device ID | K940557 |
| 510k Number | K940557 |
| Device Name: | STAPHYTECT-OD |
| Classification | Staphylococcus Aureus Protein A Insoluble |
| Applicant | UNIPATH LTD. NORSE ROAD Bedford Mk41 Oqg, GB |
| Contact | Louise Roberts |
| Correspondent | Louise Roberts UNIPATH LTD. NORSE ROAD Bedford Mk41 Oqg, GB |
| Product Code | LHJ |
| CFR Regulation Number | 866.3700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-02-07 |
| Decision Date | 1994-07-28 |