The following data is part of a premarket notification filed by American Scientific Products with the FDA for Myco-immune Tm Histoplasmin Latex Aggl.
| Device ID | K813359 |
| 510k Number | K813359 |
| Device Name: | MYCO-IMMUNE TM HISTOPLASMIN LATEX AGGL |
| Classification | Antigens, Histoplasma Capsulatum, All |
| Applicant | AMERICAN SCIENTIFIC PRODUCTS 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 | 1981-11-30 |
| Decision Date | 1981-12-31 |