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 For Measles-g Antibodies Flyorescent.
| Device ID | K853067 |
| 510k Number | K853067 |
| Device Name: | FIAX TEST KIT FOR MEASLES-G ANTIBODIES FLYORESCENT |
| Classification | Antiserum, Fluorescent, Rubeola |
| Applicant | IDT, A DIVISION OF WHITTAKER M.A. BIOPRODUCTS 2050 CONCOURSE DR. San Jose, CA 95131 |
| Contact | Louise Harris |
| Correspondent | Louise Harris IDT, A DIVISION OF WHITTAKER M.A. BIOPRODUCTS 2050 CONCOURSE DR. San Jose, CA 95131 |
| Product Code | GRE |
| CFR Regulation Number | 866.3520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-22 |
| Decision Date | 1985-10-22 |