The following data is part of a premarket notification filed by Oxoid, Ltd. with the FDA for Dryspot E.coli 0157 Kit.
| Device ID | K993401 |
| 510k Number | K993401 |
| Device Name: | DRYSPOT E.COLI 0157 KIT |
| Classification | Antisera, All Types, Escherichia Coli |
| Applicant | OXOID, LTD. WADE RD. Basingstoke, Hampshire, GB Rg24 8pw |
| Contact | Amanda Sheppard |
| Correspondent | Amanda Sheppard OXOID, LTD. WADE RD. Basingstoke, Hampshire, GB Rg24 8pw |
| Product Code | GNA |
| CFR Regulation Number | 866.3255 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-08 |
| Decision Date | 2000-02-28 |