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 Varicella Antibody Serology.
| Device ID | K853540 |
| 510k Number | K853540 |
| Device Name: | FIAX TEST KIT FOR VARICELLA ANTIBODY SEROLOGY |
| Classification | Antiserum, Cf, Varicella-zoster |
| 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 | GQX |
| CFR Regulation Number | 866.3900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-23 |
| Decision Date | 1986-02-04 |