The following data is part of a premarket notification filed by Tech America Diagnostics with the FDA for Autoflour Iii System.
| Device ID | K841984 |
| 510k Number | K841984 |
| Device Name: | AUTOFLOUR III SYSTEM |
| Classification | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control |
| Applicant | TECH AMERICA DIAGNOSTICS 348-A RANCHEROS DR. San Marcos, CA 92069 |
| Contact | Judith A Gawarecki |
| Correspondent | Judith A Gawarecki TECH AMERICA DIAGNOSTICS 348-A RANCHEROS DR. San Marcos, CA 92069 |
| Product Code | DHN |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-05-15 |
| Decision Date | 1984-11-01 |