The following data is part of a premarket notification filed by Hemotec, Inc. with the FDA for Hemotec Act I System.
| Device ID | K843459 |
| 510k Number | K843459 |
| Device Name: | HEMOTEC ACT I SYSTEM |
| Classification | Activated Whole Blood Clotting Time |
| 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 | JBP |
| CFR Regulation Number | 864.7140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-05 |
| Decision Date | 1984-12-12 |