The following data is part of a premarket notification filed by Mercia Diagnostics Ltd. with the FDA for Candidate(r) Super.
| Device ID | K863499 |
| 510k Number | K863499 |
| Device Name: | CANDIDATE(R) SUPER |
| Classification | Candida Spp., Direct Antigen, Id |
| 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 | LRF |
| CFR Regulation Number | 866.3165 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-09 |
| Decision Date | 1987-03-19 |