The following data is part of a premarket notification filed by Mercia Diagnostics Ltd. with the FDA for Captia(r) Toxo-m: An Enzyme Immunoassay.
| Device ID | K871746 |
| 510k Number | K871746 |
| Device Name: | CAPTIA(R) TOXO-M: AN ENZYME IMMUNOASSAY |
| Classification | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii |
| Applicant | MERCIA DIAGNOSTICS LTD. MERCIA HOUSEET BROADFORD PARK Guildford, Surrey England, GB Gu4 8ew |
| Contact | Louise Olliver |
| Correspondent | Louise Olliver MERCIA DIAGNOSTICS LTD. MERCIA HOUSEET BROADFORD PARK Guildford, Surrey England, GB Gu4 8ew |
| Product Code | LGD |
| CFR Regulation Number | 866.3780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-05-05 |
| Decision Date | 1987-07-31 |