The following data is part of a premarket notification filed by Mercia Diagnostics Ltd. with the FDA for Rotascreen Eia.
| Device ID | K873740 |
| 510k Number | K873740 |
| Device Name: | ROTASCREEN EIA |
| Classification | Enzyme Linked Immunoabsorbent Assay, Rotavirus |
| Applicant | MERCIA DIAGNOSTICS LTD. MERCIA HOUSEET BROADFORD PARK Guildford, Surrey England, GB Gu4 8ew |
| Contact | Lewis (phd) |
| Correspondent | Lewis (phd) MERCIA DIAGNOSTICS LTD. MERCIA HOUSEET BROADFORD PARK Guildford, Surrey England, GB Gu4 8ew |
| Product Code | LIQ |
| CFR Regulation Number | 866.3405 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-09-15 |
| Decision Date | 1987-11-27 |