The following data is part of a premarket notification filed by Immuno-mycologics, Inc. with the FDA for Alpha Cryptococcal Antigen Eia.
| Device ID | K120946 |
| 510k Number | K120946 |
| Device Name: | ALPHA CRYPTOCOCCAL ANTIGEN EIA |
| Classification | Antigen, Elisa, Cryptococcus |
| Applicant | IMMUNO-MYCOLOGICS, INC. 116 S Crawford Ave Norman, OK 73069 |
| Contact | Sean K Bauman |
| Correspondent | Sean K Bauman IMMUNO-MYCOLOGICS, INC. 116 S Crawford Ave Norman, OK 73069 |
| Product Code | MDU |
| CFR Regulation Number | 866.3165 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-29 |
| Decision Date | 2012-12-17 |
| Summary: | summary |