The following data is part of a premarket notification filed by Immuno-mycologics, Inc. with the FDA for Anti-coccidioides Serum #cf10028x.
| Device ID | K791388 |
| 510k Number | K791388 |
| Device Name: | ANTI-COCCIDIOIDES SERUM #CF10028X |
| Classification | Antiserum, Positive Control, Coccidioides Immitis |
| Applicant | IMMUNO-MYCOLOGICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GMH |
| CFR Regulation Number | 866.3135 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-07-11 |
| Decision Date | 1979-08-16 |