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) Assay.
| Device ID | K071587 |
| 510k Number | K071587 |
| Device Name: | ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST) ASSAY |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | INVERNESS MEDICAL INNOVATIONS, INC. 51 SAWYER RD., SUITE 200 Waltham, MA 02453 |
| Contact | James Delaney |
| Correspondent | James Delaney INVERNESS MEDICAL INNOVATIONS, INC. 51 SAWYER RD., SUITE 200 Waltham, MA 02453 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-06-11 |
| Decision Date | 2007-07-30 |
| Summary: | summary |