HEMOTEC, HEPCON/SYS B-10 HEPARIN/PROTAM
Device Facts
| Record ID | K841021 |
|---|---|
| Device Name | HEMOTEC, HEPCON/SYS B-10 HEPARIN/PROTAM |
| Applicant | Hemotec, Inc. |
| Product Code | JOX · Hematology |
| Decision Date | May 25, 1984 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.5680 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An automated heparin analyzer is a device used to determine the heparin level in a blood sample by mixing the sample with protamine (a heparin-neutralizing substance) and determining photometrically the onset of air-activated clotting. The analyzer also determines the amount of protamine necessary to neutralize the heparin in the patient's circulation.
Special Controls
*Classification.* Class II (special controls).
