The following data is part of a premarket notification filed by Intl. Diagnostic Technology with the FDA for Fiax Test Kit For Anti-cytomegalorirus.
| Device ID | K791948 |
| 510k Number | K791948 |
| Device Name: | FIAX TEST KIT FOR ANTI-CYTOMEGALORIRUS |
| Classification | Antigen, Cf (including Cf Control), Cytomegalovirus |
| Applicant | INTL. DIAGNOSTIC TECHNOLOGY 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GQH |
| CFR Regulation Number | 866.3175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-10-01 |
| Decision Date | 1979-11-16 |