The following data is part of a premarket notification filed by Intl. Diagnostic Technology with the FDA for Fiax Test Kit For Anti-toxoplasma Antibo.
Device ID | K790464 |
510k Number | K790464 |
Device Name: | FIAX TEST KIT FOR ANTI-TOXOPLASMA ANTIBO |
Classification | Antigens, If, Toxoplasma Gondii |
Applicant | INTL. DIAGNOSTIC TECHNOLOGY 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GLZ |
CFR Regulation Number | 866.3780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-03-05 |
Decision Date | 1979-06-13 |