Browse hierarchy: [Hematology (HE)](/submissions/HE) → [Subpart G — Manual Hematology Devices](/submissions/HE/subpart-g%E2%80%94manual-hematology-devices) → [21 CFR 864.6160](/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/864.6160) → GKM — Hand-Tally, Differential

# GKM · Hand-Tally, Differential

_Hematology · 21 CFR 864.6160 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/GKM

## Overview

- **Product Code:** GKM
- **Device Name:** Hand-Tally, Differential
- **Regulation:** [21 CFR 864.6160](/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/864.6160)
- **Device Class:** 1
- **Review Panel:** [Hematology](/submissions/HE)

## 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 (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K874188](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/GKM/K874188.md) | COULTER IMMUNOPREP LEUKOCYTE/Q-PREP IMMUNO WRK STA | Coulter Electronics, Inc. | Jan 19, 1988 | SESE |
| [K854685](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/GKM/K854685.md) | DIGITAL-9 KEY LEUCOCYTE COUNTER | Future Impex Corp. | Apr 4, 1986 | SESE |
| [K841026](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/GKM/K841026.md) | MANUAL BLOOD CELL COUNTING DEVICE | Instrumentation Laboratory CO | Apr 4, 1984 | SESE |
| [K771580](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/GKM/K771580.md) | TEKTALLY II | Scientific Products | Sep 2, 1977 | SESE |

## Top Applicants

- Coulter Electronics, Inc. — 1 clearance
- Future Impex Corp. — 1 clearance
- Instrumentation Laboratory CO — 1 clearance
- Scientific Products — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/GKM](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/GKM)

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