GJP · Control, Platelet
Hematology · 21 CFR 864.8625 · Class 2
Overview
| Product Code | GJP |
|---|---|
| Device Name | Control, Platelet |
| Regulation | 21 CFR 864.8625 |
| Device Class | Class 2 |
| Review Panel | Hematology |
Identification
A hematology quality control mixture is a device used to ascertain the accuracy and precision of manual, semiautomated, and automated determinations of cell parameters such as white cell count (WBC), red cell count (RBC), platelet count (PLT), hemoglobin, hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC).
Classification Rationale
Class II (special controls). Except when intended for use in blood components, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Special Controls
*Classification.* Class II (special controls). Except when intended for use in blood components, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K880608 | MSI-PC | Medical Specialties, Inc. | Mar 21, 1988 | SESE |
| K823930 | HEMATOLOGY QUALITY CONTROL MIXTURE | Fisher Scientific Co., LLC | Feb 1, 1983 | SESE |
| K771588 | PLATELET CONTROLS NORMAL & ABNORMAL | Dade, Baxter Travenol Diagnostics, Inc. | Aug 25, 1977 | SESE |
| K770655 | LATELET DETERMIBATION KIT, UL 800 | Bd Becton Dickinson Vacutainer Systems Preanalytic | Jun 24, 1977 | SESE |
Top Applicants
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 1 clearance
- Dade, Baxter Travenol Diagnostics, Inc. — 1 clearance
- Fisher Scientific Co., LLC — 1 clearance
- Medical Specialties, Inc. — 1 clearance
