The following data is part of a premarket notification filed by Mercia Diagnostics Ltd. with the FDA for Trichomate(r) Super.
| Device ID | K875138 |
| 510k Number | K875138 |
| Device Name: | TRICHOMATE(R) SUPER |
| Classification | Kit, Screening, Trichomonas |
| 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 | JWZ |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-15 |
| Decision Date | 1988-05-13 |