GHY · Hematocrit, Tube, Rack, Sealer, Holder
Hematology · 21 CFR 864.6400 · Class 2
Overview
| Product Code | GHY |
|---|---|
| Device Name | Hematocrit, Tube, Rack, Sealer, Holder |
| Regulation | 21 CFR 864.6400 |
| Device Class | Class 2 |
| Review Panel | Hematology |
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.
Classification Rationale
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.
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.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K883185 | SAFECRIT PLASTIC MICROHEMATOCRIT TUBES | Norfolk Scientific, Inc. | Aug 18, 1988 | SESE |
| K881186 | MICROHEMATOCRIT TUBES, HEPARIN & MICROHEMA TUBE,PL | Helps Products, Inc. | May 13, 1988 | SESE |
Top Applicants
- Helps Products, Inc. — 1 clearance
- Norfolk Scientific, Inc. — 1 clearance
