The following data is part of a premarket notification filed by Tech America Diagnostics with the FDA for Autofluor Iv System.
| Device ID | K843181 |
| 510k Number | K843181 |
| Device Name: | AUTOFLUOR IV SYSTEM |
| Classification | Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control |
| Applicant | TECH AMERICA DIAGNOSTICS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DBM |
| CFR Regulation Number | 866.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-13 |
| Decision Date | 1984-09-17 |