General Biometrics, Inc. · Class II · Cleared Sep 13, 1989
| K-number | K894975 |
| Device name | IMMUNODOT INFECTIOUS MONONUCLEOSIS TEST |
| Applicant | General Biometrics, Inc. |
| Product code | KTN |
| Device class | Class II |
| Decision date | Sep 13, 1989 |
| Decision | Substantially Equivalent |
| Regulation | 866.5640 |
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