The following data is part of a premarket notification filed by Immuno-mycologics, Inc. with the FDA for Ei-candida Enzyme Immunoassay Ei1001.
| Device ID | K843286 |
| 510k Number | K843286 |
| Device Name: | EI-CANDIDA ENZYME IMMUNOASSAY EI1001 |
| Classification | Candida Spp., Direct Antigen, Id |
| Applicant | IMMUNO-MYCOLOGICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LRF |
| CFR Regulation Number | 866.3165 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-21 |
| Decision Date | 1984-10-01 |