21 CFR 864.6400 — Hematocrit, Tube, Rack, Sealer, Holder
Hematology (HE) · Part 864 Subpart G—Manual Hematology Devices · § 864.6400
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| GHY | Hematocrit, Tube, Rack, Sealer, Holder | 2 | 2 | |
| GKG | Centrifuge, Hematocrit | 2 | 11 | |
| JPI | Device, Hematocrit Measuring | 2 | 15 |
Special Controls
GHY — Hematocrit, Tube, Rack, Sealer, Holder
*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.
eCFR
GKG — Centrifuge, Hematocrit
*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.
eCFR
JPI — Device, Hematocrit Measuring
*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.
eCFR
