The following data is part of a premarket notification filed by Oxoid, Ltd. with the FDA for Oxoid Pylori Test Kit, Model Dr0130m.
| Device ID | K012588 |
| 510k Number | K012588 |
| Device Name: | OXOID PYLORI TEST KIT, MODEL DR0130M |
| Classification | Helicobacter Pylori |
| 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 | LYR |
| CFR Regulation Number | 866.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-10 |
| Decision Date | 2001-12-10 |