The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Cmvgen.
| Device ID | K974456 |
| 510k Number | K974456 |
| Device Name: | CMVGEN |
| Classification | Antigen, Iha, Cytomegalovirus |
| Applicant | INSTRUMENTATION LABORATORY CO. 113 HARTWELL AVE. Lexington, MA 02173 |
| Contact | Carol Marble |
| Correspondent | Carol Marble INSTRUMENTATION LABORATORY CO. 113 HARTWELL AVE. Lexington, MA 02173 |
| Product Code | LJO |
| CFR Regulation Number | 866.3175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-25 |
| Decision Date | 1998-05-01 |
| Summary: | summary |