General Biometrics, Inc. · Class II · Cleared May 7, 1991
| K-number | K911850 |
| Device name | IMMUNWELL SJOGREN`S SYNDROME B (LA) ANTIBODY TEST |
| Applicant | General Biometrics, Inc. |
| Product code | LKO |
| Device class | Class II |
| Decision date | May 7, 1991 |
| Decision | Substantially Equivalent |
| Regulation | 866.5100 |
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