The following data is part of a premarket notification filed by Mercia Diagnostics Ltd. with the FDA for Captia Cmv-ta.
| Device ID | K915479 |
| 510k Number | K915479 |
| Device Name: | CAPTIA CMV-TA |
| Classification | Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus |
| Applicant | MERCIA DIAGNOSTICS LTD. MERCIA HOUSEET BROADFORD PARK Guildford, Surrey England, GB Gu4 8ew |
| Contact | H Lewis |
| Correspondent | H Lewis MERCIA DIAGNOSTICS LTD. MERCIA HOUSEET BROADFORD PARK Guildford, Surrey England, GB Gu4 8ew |
| Product Code | LFZ |
| CFR Regulation Number | 866.3175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-06 |
| Decision Date | 1992-05-04 |