The following data is part of a premarket notification filed by Alere San Diego, Inc (formally Biosite Incorporate with the FDA for Inratio2 Pi/nr Monitoring System; Inratio Pt/inr Test Strip.
| Device ID | K110212 |
| 510k Number | K110212 |
| Device Name: | INRATIO2 PI/NR MONITORING SYSTEM; INRATIO PT/INR TEST STRIP |
| Classification | Test, Time, Prothrombin |
| Applicant | ALERE SAN DIEGO, INC (FORMALLY BIOSITE INCORPORATE 9975 Summers Ridge Road San Diego, CA 92121 |
| Contact | Mara Caler |
| Correspondent | Mara Caler ALERE SAN DIEGO, INC (FORMALLY BIOSITE INCORPORATE 9975 Summers Ridge Road San Diego, CA 92121 |
| Product Code | GJS |
| CFR Regulation Number | 864.7750 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-25 |
| Decision Date | 2012-05-01 |
| Summary: | summary |