The following data is part of a premarket notification filed by Diatech, Inc. with the FDA for Dia T1, T2 & T3.
| Device ID | K842286 |
| 510k Number | K842286 |
| Device Name: | DIA T1, T2 & T3 |
| Classification | Mixture, Hematology Quality Control |
| Applicant | DIATECH, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JPK |
| CFR Regulation Number | 864.8625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-06-13 |
| Decision Date | 1984-09-11 |