The following data is part of a premarket notification filed by I M, Inc. with the FDA for Anti-histoplasma Control Serum(mycelial).
| Device ID | K760831 |
| 510k Number | K760831 |
| Device Name: | ANTI-HISTOPLASMA CONTROL SERUM(MYCELIAL) |
| Classification | Antiserum, Positive Control, Histoplasma Capsulatum |
| Applicant | I M, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GMK |
| CFR Regulation Number | 866.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-10-13 |
| Decision Date | 1976-11-01 |