The following data is part of a premarket notification filed by Immuno-mycologics, Inc. with the FDA for Histoplasma Yeast Anti #cf10021x.
| Device ID | K791393 |
| 510k Number | K791393 |
| Device Name: | HISTOPLASMA YEAST ANTI #CF10021X |
| Classification | Antigens, Histoplasma Capsulatum, All |
| Applicant | IMMUNO-MYCOLOGICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GMJ |
| CFR Regulation Number | 866.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-07-11 |
| Decision Date | 1979-08-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816387020377 | K791393 | 000 |
| 00816387020360 | K791393 | 000 |