The following data is part of a premarket notification filed by Hemotec, Inc. with the FDA for Additional Hemotec Hepcon/sys B-10 Coagulation Car.
| Device ID | K853789 |
| 510k Number | K853789 |
| Device Name: | ADDITIONAL HEMOTEC HEPCON/SYS B-10 COAGULATION CAR |
| Classification | System, Multipurpose For In Vitro Coagulation Studies |
| Applicant | HEMOTEC, INC. 14 CODDING RD. Attleboro, MA 02703 |
| Contact | William A Morton |
| Correspondent | William A Morton HEMOTEC, INC. 14 CODDING RD. Attleboro, MA 02703 |
| Product Code | JPA |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-10 |
| Decision Date | 1985-10-04 |