The following data is part of a premarket notification filed by Hemosense, Inc. with the FDA for Inratio Self-test.
| Device ID | K021923 |
| 510k Number | K021923 |
| Device Name: | INRATIO SELF-TEST |
| Classification | Test, Time, Prothrombin |
| Applicant | HEMOSENSE, INC. 600 VALLEY WAY Milpitas, CA 95035 |
| Contact | Judith Blunt |
| Correspondent | Judith Blunt HEMOSENSE, INC. 600 VALLEY WAY Milpitas, CA 95035 |
| Product Code | GJS |
| CFR Regulation Number | 864.7750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-11 |
| Decision Date | 2002-10-24 |
| Summary: | summary |