The following data is part of a premarket notification filed by Baxter Diagnostics, Inc. with the FDA for Dade Innovin Ii.
| Device ID | K935702 |
| 510k Number | K935702 |
| Device Name: | DADE INNOVIN II |
| Classification | Test, Time, Prothrombin |
| Applicant | BAXTER DIAGNOSTICS, INC. SCIENTIFIC PRODUCTS DIV. 1430 WAUKEGAN RD. Mcgaw Park, IL 60085 |
| Contact | Ronald H Lentsch, Ph.d |
| Correspondent | Ronald H Lentsch, Ph.d BAXTER DIAGNOSTICS, INC. SCIENTIFIC PRODUCTS DIV. 1430 WAUKEGAN RD. Mcgaw Park, IL 60085 |
| Product Code | GJS |
| CFR Regulation Number | 864.7750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-30 |
| Decision Date | 1994-11-22 |