Browse hierarchy: [Hematology (HE)](/submissions/HE) → [Subpart J — Products Used In Establishments That Manufacture Blood and Blood Products](/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products) → [21 CFR 864.9185](/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/864.9185) → KSY — Boxes, View, Blood Grouping

# KSY · Boxes, View, Blood Grouping

_Hematology · 21 CFR 864.9185 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSY

## Overview

- **Product Code:** KSY
- **Device Name:** Boxes, View, Blood Grouping
- **Regulation:** [21 CFR 864.9185](/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/864.9185)
- **Device Class:** 1
- **Review Panel:** [Hematology](/submissions/HE)

## 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](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSY/K792306.md) | RH VIEWBOX | Tekpro | Dec 4, 1979 | SESE |

## Top Applicants

- Tekpro — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSY](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSY)

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