The following data is part of a premarket notification filed by Immuno-mycologics, Inc. with the FDA for La-sporo Antibody System.
| Device ID | K802427 |
| 510k Number | K802427 |
| Device Name: | LA-SPORO ANTIBODY SYSTEM |
| Classification | Antisera, Fluorescent, Sporothrix Schenekii |
| Applicant | IMMUNO-MYCOLOGICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GMA |
| CFR Regulation Number | 866.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-10-06 |
| Decision Date | 1980-10-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816387020865 | K802427 | 000 |