The following data is part of a premarket notification filed by Biosite Incorporated with the FDA for Inratio/inratio2 Test Strips.
| Device ID | K092987 |
| 510k Number | K092987 |
| Device Name: | INRATIO/INRATIO2 TEST STRIPS |
| Classification | Test, Time, Prothrombin |
| Applicant | BIOSITE INCORPORATED 9975 SUMMERS RIDGE RD San Diego, CA 92121 |
| Contact | Karin A Huges |
| Correspondent | Karin A Huges BIOSITE INCORPORATED 9975 SUMMERS RIDGE RD San Diego, CA 92121 |
| Product Code | GJS |
| CFR Regulation Number | 864.7750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-28 |
| Decision Date | 2010-06-11 |
| Summary: | summary |