The following data is part of a premarket notification filed by Intl. Diagnostic Technology with the FDA for Fiax Toxo-m Antibodies Test Kit.
Device ID | K850591 |
510k Number | K850591 |
Device Name: | FIAX TOXO-M ANTIBODIES TEST KIT |
Classification | Antigens, If, Toxoplasma Gondii |
Applicant | INTL. DIAGNOSTIC TECHNOLOGY 2050 CONCOURSE DR. San Jose, CA 95131 |
Contact | Duff Self |
Correspondent | Duff Self INTL. DIAGNOSTIC TECHNOLOGY 2050 CONCOURSE DR. San Jose, CA 95131 |
Product Code | GLZ |
CFR Regulation Number | 866.3780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-02-14 |
Decision Date | 1985-04-30 |