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 For Anti-rubella Antibody.
Device ID | K772219 |
510k Number | K772219 |
Device Name: | FIAX TEST FOR ANTI-RUBELLA ANTIBODY |
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 | 1977-12-05 |
Decision Date | 1978-01-20 |