JCG · Fluid, Diluting, Manual Cell
Hematology · 21 CFR 864.8200 · Class 1
Overview
| Product Code | JCG |
|---|---|
| Device Name | Fluid, Diluting, Manual 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 |
|---|---|---|---|---|
| K892658 | SDI PREPAX COUNTAPETTE KIT | Scientific Distributors, Inc. | May 24, 1989 | SESE |
Top Applicants
- Scientific Distributors, Inc. — 1 clearance
