The following data is part of a premarket notification filed by Hemotec, Inc. with the FDA for Hepcon/system B-10 Heparin Assay/screen/cartridges.
| Device ID | K884590 |
| 510k Number | K884590 |
| Device Name: | HEPCON/SYSTEM B-10 HEPARIN ASSAY/SCREEN/CARTRIDGES |
| Classification | Assay, Heparin |
| Applicant | HEMOTEC, INC. 7103 SOUTH REVERE PKWY. Englewood, CO 80112 |
| Contact | Baugh, Phd |
| Correspondent | Baugh, Phd HEMOTEC, INC. 7103 SOUTH REVERE PKWY. Englewood, CO 80112 |
| Product Code | KFF |
| CFR Regulation Number | 864.7525 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-03 |
| Decision Date | 1989-01-10 |