The following data is part of a premarket notification filed by Worthington Diagnostic Systems with the FDA for Easytouch Tromboplastin Reagent.
| Device ID | K832427 |
| 510k Number | K832427 |
| Device Name: | EASYTOUCH TROMBOPLASTIN REAGENT |
| Classification | Test, Time, Prothrombin |
| Applicant | WORTHINGTON DIAGNOSTIC SYSTEMS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GJS |
| CFR Regulation Number | 864.7750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-07-22 |
| Decision Date | 1983-10-14 |