GKX · Instrument, Automated Platelet Counting
Hematology · 21 CFR 864.5200 · Class 2
Overview
| Product Code | GKX |
|---|---|
| Device Name | Instrument, Automated Platelet Counting |
| Regulation | 21 CFR 864.5200 |
| Device Class | Class 2 |
| Review Panel | Hematology |
| 3rd-Party Reviewable | Yes |
Identification
An automated cell counter is a fully-automated or semi-automated device used to count red blood cells, white blood cells, or blood platelets using a sample of the patient's peripheral blood (blood circulating in one of the body's extremities, such as the arm). These devices may also measure hemoglobin or hematocrit and may also calculate or measure one or more of the red cell indices (the erythrocyte mean corpuscular volume, the mean corpuscular hemoglobin, or the mean corpuscular hemoglobin concentration). These devices may use either an electronic particle counting method or an optical counting method.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K014203 | ABX MICROS 60 HEMATOLOGY ANALYZER | Abx Diagnostics | Feb 28, 2002 | SESE |
| K840948 | CLEAR POROUS PLASTIC-HYPOALLERGENIC | Gainor Medical | Aug 14, 1984 | SESE |
Top Applicants
- Abx Diagnostics — 1 clearance
- Gainor Medical — 1 clearance
