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 |