Browse hierarchy: [Hematology (HE)](/submissions/HE) → [Subpart I — Hematology Reagents](/submissions/HE/subpart-i%E2%80%94hematology-reagents) → [21 CFR 864.8185](/submissions/HE/subpart-i%E2%80%94hematology-reagents/864.8185) → KSA — Calibrator For Red-Cell And White-Cell Counting

# KSA · Calibrator For Red-Cell And White-Cell Counting

_Hematology · 21 CFR 864.8185 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/KSA

## Overview

- **Product Code:** KSA
- **Device Name:** Calibrator For Red-Cell And White-Cell Counting
- **Regulation:** [21 CFR 864.8185](/submissions/HE/subpart-i%E2%80%94hematology-reagents/864.8185)
- **Device Class:** 2
- **Review Panel:** [Hematology](/submissions/HE)

## Identification

A calibrator for red cell and white cell counting is a device that resembles red or white blood cells and that is used to set instruments intended to count red cells, white cells, or both. It is a suspension of particles or cells whose size, shape, concentration, and other characteristics have been precisely and accurately determined.

## Classification Rationale

Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

## Special Controls

*Classification.* Class II (special controls). The 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 (8 of 8)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K943268](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/KSA/K943268.md) | SCS-1000 (SYSMEX CALIBRATOR SYSTEM) | Streck Laboratories, Inc. | Dec 15, 1994 | SESE |
| [K897060](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/KSA/K897060.md) | CBC-CAL(TM) PLUS HEMATOLOGY CALIBRATOR/MULTIPLE | R&D Systems, Inc. | Jan 2, 1990 | SESE |
| [K881161](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/KSA/K881161.md) | TECH-CAL(TM)/MULTIPLE | R&D Systems, Inc. | May 2, 1988 | SESE |
| [K864664](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/KSA/K864664.md) | H-1 SETPOINT PLATELET AND RBC/WBC CALIBRATORS | Technicon Instruments Corp. | Feb 6, 1987 | SESE |
| [K854823](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/KSA/K854823.md) | CBC-CAL/MULTIPLE | R&D Systems, Inc. | Feb 13, 1986 | SESE |
| [K844708](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/KSA/K844708.md) | TRI-COUNT CALIBRATOR | Hematology Marketing Assoc. | Mar 5, 1985 | SESE |
| [K813530](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/KSA/K813530.md) | HEMOTOLOGY CALIBRATOR | American Dade | Feb 22, 1982 | SESE |
| [K813375](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/KSA/K813375.md) | HEMATOLOGY CALIBRATOR S-CAL | Coulter Electronics, Inc. | Feb 4, 1982 | SESE |

## Top Applicants

- R&D Systems, Inc. — 3 clearances
- American Dade — 1 clearance
- Coulter Electronics, Inc. — 1 clearance
- Hematology Marketing Assoc. — 1 clearance
- Streck Laboratories, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/KSA](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/KSA)

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