The following data is part of a premarket notification filed by Intl. Diagnostic Technology with the FDA for Fiax Rheumatoid Factor Test Kit.
| Device ID | K812968 |
| 510k Number | K812968 |
| Device Name: | FIAX RHEUMATOID FACTOR TEST KIT |
| Classification | System, Test, Rheumatoid Factor |
| Applicant | INTL. DIAGNOSTIC TECHNOLOGY 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DHR |
| CFR Regulation Number | 866.5775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-10-22 |
| Decision Date | 1981-11-06 |