| K-number | K853137 |
| Device name | CMV TEST |
| Applicant | Gull Laboratories, Inc. |
| Product code | GQI |
| Device class | Class II |
| Decision date | Nov 14, 1985 |
| Decision | Substantially Equivalent |
| Regulation | 866.3175 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov