← Product Code [KSA](/submissions/HE/subpart-i%E2%80%94hematology-reagents/KSA) · K813375

# HEMATOLOGY CALIBRATOR S-CAL (K813375)

_Coulter Electronics, Inc. · KSA · Feb 4, 1982 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/KSA/K813375

## Device Facts

- **Applicant:** Coulter Electronics, Inc.
- **Product Code:** [KSA](/submissions/HE/subpart-i%E2%80%94hematology-reagents/KSA.md)
- **Decision Date:** Feb 4, 1982
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.8185
- **Device Class:** Class 2
- **Review Panel:** Hematology

## Regulatory 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.

## 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.

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/KSA/K813375](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/KSA/K813375)

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