The following data is part of a premarket notification filed by Mercia Diagnostics Ltd. with the FDA for Captia(r) Syphilis M, Modification.
| Device ID | K904524 |
| 510k Number | K904524 |
| Device Name: | CAPTIA(R) SYPHILIS M, MODIFICATION |
| Classification | Enzyme Linked Immunoabsorption Assay, Treponema Pallidum |
| Applicant | MERCIA DIAGNOSTICS LTD. MERCIA HOUSEET BROADFORD PARK Guildford, Surrey England, GB Gu4 8ew |
| Contact | D. H Lewis |
| Correspondent | D. H Lewis MERCIA DIAGNOSTICS LTD. MERCIA HOUSEET BROADFORD PARK Guildford, Surrey England, GB Gu4 8ew |
| Product Code | LIP |
| CFR Regulation Number | 866.3830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-27 |
| Decision Date | 1990-12-26 |