The following data is part of a premarket notification filed by Cardiovascular Diagnostics, Inc. with the FDA for Enoxaparin Test Card.
| Device ID | K013305 |
| 510k Number | K013305 |
| Device Name: | ENOXAPARIN TEST CARD |
| Classification | Assay, Heparin |
| Applicant | CARDIOVASCULAR DIAGNOSTICS, INC. 9401 GLOBE CENTER DR. SUITE 140 Morrisville, NC 27560 |
| Contact | Peter Scott |
| Correspondent | Peter Scott CARDIOVASCULAR DIAGNOSTICS, INC. 9401 GLOBE CENTER DR. SUITE 140 Morrisville, NC 27560 |
| Product Code | KFF |
| CFR Regulation Number | 864.7525 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-04 |
| Decision Date | 2002-08-23 |
| Summary: | summary |