The following data is part of a premarket notification filed by Ischemia Technologies, Inc. with the FDA for Albumin Cobalt Binding Test (acb Test).
| Device ID | K023824 |
| 510k Number | K023824 |
| Device Name: | ALBUMIN COBALT BINDING TEST (ACB TEST) |
| Classification | Test, Albumin Cobalt Binding |
| Applicant | ISCHEMIA TECHNOLOGIES, INC. 4600 WEST 60TH AVE. Arvada, CO 80003 |
| Contact | Peter Crosby |
| Correspondent | Peter Crosby ISCHEMIA TECHNOLOGIES, INC. 4600 WEST 60TH AVE. Arvada, CO 80003 |
| Product Code | NJV |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-11-18 |
| Decision Date | 2003-02-14 |