GHO · Hemocytometer
Hematology · 21 CFR 864.6160 · Class 1
Overview
| Product Code | GHO |
|---|---|
| Device Name | Hemocytometer |
| Regulation | 21 CFR 864.6160 |
| Device Class | Class 1 |
| Review Panel | Hematology |
Identification
A manual blood cell counting device is a device used to count red blood cells, white blood cells, or blood platelets.
Classification Rationale
Class I (general controls). This 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 (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K871671 | URINOSCOPY FUNNEL | Portable Medical Laboratories, Inc. | May 20, 1987 | SESE |
| K770980 | EMATOLOGY DILUENT RESERVOIR CLOSURE | Bd Becton Dickinson Vacutainer Systems Preanalytic | Jul 11, 1977 | SESE |
Top Applicants
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 1 clearance
- Portable Medical Laboratories, Inc. — 1 clearance
