The following data is part of a premarket notification filed by Hemotec, Inc. with the FDA for Hepcon System B-10 Activated Clot Time & Heparin.
| Device ID | K875089 |
| 510k Number | K875089 |
| Device Name: | HEPCON SYSTEM B-10 ACTIVATED CLOT TIME & HEPARIN |
| Classification | System, Multipurpose For In Vitro Coagulation Studies |
| 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 | JPA |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-09 |
| Decision Date | 1988-03-09 |