HMS PURPLE AND BLACK HEPARIN CARTRIDGES & CONTROL
Device Facts
| Record ID | K922031 |
|---|---|
| Device Name | HMS PURPLE AND BLACK HEPARIN CARTRIDGES & CONTROL |
| Applicant | Medtronic Hemotec, Inc. |
| Product Code | JOX · Hematology |
| Decision Date | Jul 21, 1992 |
| 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).
