The following data is part of a premarket notification filed by Idt, A Division Of Whittaker M.a. Bioproducts with the FDA for Fiax Test Kit.
| Device ID | K782041 |
| 510k Number | K782041 |
| Device Name: | FIAX TEST KIT |
| Classification | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control |
| Applicant | IDT, A DIVISION OF WHITTAKER M.A. BIOPRODUCTS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DHN |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-12-07 |
| Decision Date | 1979-01-03 |