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 |