The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Handheld Base Unit.
| Device ID | K072920 |
| 510k Number | K072920 |
| Device Name: | HANDHELD BASE UNIT |
| Classification | Test, Time, Prothrombin |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Contact | Jason Fisher |
| Correspondent | Jason Fisher ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Product Code | GJS |
| CFR Regulation Number | 864.7750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-10-15 |
| Decision Date | 2008-01-31 |