The following data is part of a premarket notification filed by Hemotec, Inc. with the FDA for Hepcol System B-10 & B-10-p.
| Device ID | K830665 |
| 510k Number | K830665 |
| Device Name: | HEPCOL SYSTEM B-10 & B-10-P |
| 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 | 1983-03-03 |
| Decision Date | 1983-06-08 |