The following data is part of a premarket notification filed by Hemotec, Inc. with the FDA for Hemotec Citrated Whole Blood Coagulation Controls.
| Device ID | K854376 |
| 510k Number | K854376 |
| Device Name: | HEMOTEC CITRATED WHOLE BLOOD COAGULATION CONTROLS |
| 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 | 1985-10-30 |
| Decision Date | 1985-12-04 |