The following data is part of a premarket notification filed by American Scientific Products with the FDA for Fungal Immunodiffusion System.
| Device ID | K812185 |
| 510k Number | K812185 |
| Device Name: | FUNGAL IMMUNODIFFUSION SYSTEM |
| Classification | Antigen, Cf And / Or Id, Coccidioides Immitis |
| Applicant | AMERICAN SCIENTIFIC PRODUCTS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GMI |
| CFR Regulation Number | 866.3135 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-08-03 |
| Decision Date | 1981-08-25 |