GGJ · Fluid, Diluting, White-Cell
Hematology · 21 CFR 864.8200 · Class 1
Overview
| Product Code | GGJ |
|---|---|
| Device Name | Fluid, Diluting, White-Cell |
| Regulation | 21 CFR 864.8200 |
| Device Class | Class 1 |
| Review Panel | Hematology |
Identification
A blood cell diluent is a device used to dilute blood for further testing, such as blood cell counting.
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 (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K926422 | VISTA(R) HUMAN FOLLICLE-STIM HORMONE(HFSH) ASSAY | Syva Co. | Jun 2, 1993 | SESE |
Top Applicants
- Syva Co. — 1 clearance
