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 |