← Product Code [JCM](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JCM) · K820787

# HELENA ABNORMAL HBA2 QUIK COLUMN CONTROL (K820787)

_Helena Laboratories · JCM · Apr 8, 1982 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JCM/K820787

## Device Facts

- **Applicant:** Helena Laboratories
- **Product Code:** [JCM](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JCM.md)
- **Decision Date:** Apr 8, 1982
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.7415
- **Device Class:** Class 2
- **Review Panel:** Hematology

## Regulatory Identification

An abnormal hemoglobin assay is a device consisting of the reagents, apparatus, instrumentation, and controls necessary to isolate and identify abnormal genetically determined hemoglobin types.

## Special Controls

*Classification.* Class II (special controls). A control intended for use with an abnormal hemoglobin assay 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-h%E2%80%94hematology-kits-and-packages/JCM/K820787](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JCM/K820787)

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