The following data is part of a premarket notification filed by Intl. Diagnostic Technology with the FDA for Fiax Test Kit For Theophylline Quant..
| Device ID | K801642 |
| 510k Number | K801642 |
| Device Name: | FIAX TEST KIT FOR THEOPHYLLINE QUANT. |
| Classification | Enzyme Immunoassay, Theophylline |
| Applicant | INTL. DIAGNOSTIC TECHNOLOGY 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KLS |
| CFR Regulation Number | 862.3880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-07-17 |
| Decision Date | 1980-08-27 |