The following data is part of a premarket notification filed by Intl. Diagnostic Technology with the FDA for Fiax 420 Dilutor.
| Device ID | K843621 |
| 510k Number | K843621 |
| Device Name: | FIAX 420 DILUTOR |
| Classification | Station, Pipetting And Diluting, For Clinical Use |
| Applicant | INTL. DIAGNOSTIC TECHNOLOGY 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JQW |
| CFR Regulation Number | 862.2750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-14 |
| Decision Date | 1984-09-28 |