K974456 is an FDA 510(k) clearance for the CMVGEN. This device is classified as a Antigen, Iha, Cytomegalovirus (Class II - Special Controls, product code LJO).
Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on May 1, 1998, 157 days after receiving the submission on November 25, 1997.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3175.
| 510(k) Number | K974456 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 25, 1997 |
| Decision Date | May 01, 1998 |
| Days to Decision | 157 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | LJO — Antigen, Iha, Cytomegalovirus |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3175 |