The following data is part of a premarket notification filed by Immuno-mycologics, Inc. with the FDA for Alpha Histoplasma Antigen Eia Model Hag102.
| Device ID | K101407 |
| 510k Number | K101407 |
| Device Name: | ALPHA HISTOPLASMA ANTIGEN EIA MODEL HAG102 |
| Classification | Enzyme Linked Immunoabsorbent Assay, Histoplasma Capsulatum |
| Applicant | IMMUNO-MYCOLOGICS, INC. 2700 TECHNOLOGY PLACE Norman, OK 73071 |
| Contact | Sean K Bauman, Ph.d |
| Correspondent | Sean K Bauman, Ph.d IMMUNO-MYCOLOGICS, INC. 2700 TECHNOLOGY PLACE Norman, OK 73071 |
| Product Code | MIZ |
| CFR Regulation Number | 866.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-19 |
| Decision Date | 2011-07-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816387020773 | K101407 | 000 |