The following data is part of a premarket notification filed by Cetus Corp. with the FDA for Cetus Cmv Iha.
| Device ID | K822965 |
| 510k Number | K822965 |
| Device Name: | CETUS CMV IHA |
| Classification | Antigen, Iha, Cytomegalovirus |
| Applicant | CETUS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LJO |
| CFR Regulation Number | 866.3175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-10-07 |
| Decision Date | 1983-02-15 |