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 |