The following data is part of a premarket notification filed by Oxoid, Ltd. with the FDA for Staphytect Plus/dryspot Staphytect Plus.
| Device ID | K972030 |
| 510k Number | K972030 |
| Device Name: | STAPHYTECT PLUS/DRYSPOT STAPHYTECT PLUS |
| Classification | Kit, Screening, Staphylococcus Aureus |
| Applicant | OXOID, LTD. WADE RD. Basingstoke, Hampshire, GB Rg24 8pw |
| Contact | Andy Hollingsworth |
| Correspondent | Andy Hollingsworth OXOID, LTD. WADE RD. Basingstoke, Hampshire, GB Rg24 8pw |
| Product Code | JWX |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-02 |
| Decision Date | 1997-09-08 |