The following data is part of a premarket notification filed by Intl. Diagnostic Technology with the FDA for Fiax Igg Test.
| Device ID | K832821 |
| 510k Number | K832821 |
| Device Name: | FIAX IGG TEST |
| Classification | Total Spinal-fluid, Antigen, Antiserum, Control |
| Applicant | INTL. DIAGNOSTIC TECHNOLOGY 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DFI |
| CFR Regulation Number | 866.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-08-19 |
| Decision Date | 1983-10-14 |