The following data is part of a premarket notification filed by Inverness Medical Innovations, Inc. with the FDA for Smartcheck Inr System.
| Device ID | K071265 |
| 510k Number | K071265 |
| Device Name: | SMARTCHECK INR SYSTEM |
| Classification | System, Multipurpose For In Vitro Coagulation Studies |
| Applicant | INVERNESS MEDICAL INNOVATIONS, INC. 51 SAWYER RD., SUITE 200 Waltham, MA 02453 -3448 |
| Contact | Lesley Moore |
| Correspondent | Lesley Moore INVERNESS MEDICAL INNOVATIONS, INC. 51 SAWYER RD., SUITE 200 Waltham, MA 02453 -3448 |
| Product Code | JPA |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-07 |
| Decision Date | 2007-11-30 |
| Summary: | summary |