The following data is part of a premarket notification filed by Immuno-mycologics, Inc. with the FDA for Anti-aspergillus (mycelial) Contr Serum.
| Device ID | K791386 |
| 510k Number | K791386 |
| Device Name: | ANTI-ASPERGILLUS (MYCELIAL) CONTR SERUM |
| Classification | Antiserum, Positive Control, Aspergillus Spp. |
| Applicant | IMMUNO-MYCOLOGICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KFG |
| CFR Regulation Number | 866.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-07-11 |
| Decision Date | 1979-08-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816387020018 | K791386 | 000 |