KSY · Boxes, View, Blood Grouping
Hematology · 21 CFR 864.9185 · Class 1
Overview
| Product Code | KSY |
|---|---|
| Device Name | Boxes, View, Blood Grouping |
| Regulation | 21 CFR 864.9185 |
| Device Class | Class 1 |
| Review Panel | Hematology |
Identification
A blood grouping view box is a device with a glass or plastic viewing surface, which may be illuminated and heated, that is used to view cell reactions in antigen-antibody testing.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 864.9.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K792306 | RH VIEWBOX | Tekpro | Dec 4, 1979 | SESE |
Top Applicants
- Tekpro — 1 clearance
