General Biometrics, Inc. · Class II · Cleared Jan 3, 1991
| K-number | K905486 |
| Device name | IMMUNOWELL TPO (MICROSOME) TEST |
| Applicant | General Biometrics, Inc. |
| Product code | JNL |
| Device class | Class II |
| Decision date | Jan 3, 1991 |
| Decision | Substantially Equivalent |
| Regulation | 866.5870 |
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