The following data is part of a premarket notification filed by Hemotec, Inc. with the FDA for Hemotec, Hepcon/sys B-10 Heparin/protam.
| Device ID | K841021 |
| 510k Number | K841021 |
| Device Name: | HEMOTEC, HEPCON/SYS B-10 HEPARIN/PROTAM |
| Classification | Analyzer, Heparin, Automated |
| Applicant | HEMOTEC, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JOX |
| CFR Regulation Number | 864.5680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-03-12 |
| Decision Date | 1984-05-25 |