The following data is part of a premarket notification filed by Medical Device Consultants, Inc. with the FDA for Hemotec Act High Range Activated Clotting Time.
| Device ID | K860122 |
| 510k Number | K860122 |
| Device Name: | HEMOTEC ACT HIGH RANGE ACTIVATED CLOTTING TIME |
| Classification | Activated Whole Blood Clotting Time |
| Applicant | MEDICAL DEVICE CONSULTANTS, INC. 45 WEST ST. SUITE 2 Attleboro, MA 02703 |
| Contact | William Morton |
| Correspondent | William Morton MEDICAL DEVICE CONSULTANTS, INC. 45 WEST ST. SUITE 2 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 | 1986-01-14 |
| Decision Date | 1986-04-04 |