The following data is part of a premarket notification filed by Meridian Diagnostics, Inc. with the FDA for Histoplasma Capsulatum, Mycelial Phase.
| Device ID | K792708 |
| 510k Number | K792708 |
| Device Name: | HISTOPLASMA CAPSULATUM, MYCELIAL PHASE |
| Classification | Antigens, Histoplasma Capsulatum, All |
| Applicant | MERIDIAN DIAGNOSTICS, 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 | 1979-12-27 |
| Decision Date | 1980-01-17 |