The following data is part of a premarket notification filed by Hemotec, Inc. with the FDA for Hemotec Cv Whole Blood Coagulation Controls.
Device ID | K854377 |
510k Number | K854377 |
Device Name: | HEMOTEC CV WHOLE BLOOD COAGULATION CONTROLS |
Classification | Analyzer, Heparin, Automated |
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 | JOX |
CFR Regulation Number | 864.5680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-10-30 |
Decision Date | 1985-12-04 |