CRIT-LINE HEMATOCRIT ALERT
Device Facts
| Record ID | K950942 |
|---|---|
| Device Name | CRIT-LINE HEMATOCRIT ALERT |
| Applicant | In-Line Diagnostics Corp. |
| Product Code | JPI · Hematology |
| Decision Date | Mar 14, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.6400 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A hematocrit measuring device is a system consisting of instruments, tubes, racks, and a sealer and a holder. The device is used to measure the packed red cell volume in blood to determine whether the patient's total red cell volume is normal or abnormal. Abnormal states include anemia (an abnormally low total red cell volume) and erythrocytosis (an abnormally high total red cell mass). The packed red cell volume is produced by centrifuging a given volume of blood.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 864.9.
