The following data is part of a premarket notification filed by Inverness Medical Innovations, Inc. with the FDA for Ischemia Albumin Cobalt Binding Test (acb Test).
| Device ID | K053196 |
| 510k Number | K053196 |
| Device Name: | ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST) |
| Classification | Test, Albumin Cobalt Binding |
| Applicant | INVERNESS MEDICAL INNOVATIONS, INC. 51 SAWYER RD., SUITE 200 Waltham, MA 02453 -3448 |
| Contact | James M Delaney |
| Correspondent | James M Delaney INVERNESS MEDICAL INNOVATIONS, INC. 51 SAWYER RD., SUITE 200 Waltham, MA 02453 -3448 |
| Product Code | NJV |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-16 |
| Decision Date | 2005-12-16 |
| Summary: | summary |