The following data is part of a premarket notification filed by Mercia Diagnostics Ltd. with the FDA for Modified Captia(r) Toxo-m.
| Device ID | K900655 |
| 510k Number | K900655 |
| Device Name: | MODIFIED CAPTIA(R) TOXO-M |
| Classification | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii |
| 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 | LGD |
| CFR Regulation Number | 866.3780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-09 |
| Decision Date | 1990-03-06 |