Browse hierarchy: [Hematology (HE)](/submissions/HE) → [Subpart H — Hematology Kits and Packages](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages) → [21 CFR 864.7415](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/864.7415) → MLL — Hemoglobin C (Abnormal Hemoglobin Variant)

# MLL · Hemoglobin C (Abnormal Hemoglobin Variant)

_Hematology · 21 CFR 864.7415 · Class 2_

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

## Overview

- **Product Code:** MLL
- **Device Name:** Hemoglobin C (Abnormal Hemoglobin Variant)
- **Regulation:** [21 CFR 864.7415](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/864.7415)
- **Device Class:** 2
- **Review Panel:** [Hematology](/submissions/HE)
- **3rd-party reviewable:** yes

## 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.

## Classification Rationale

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.

## 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.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K923153](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/MLL/K923153.md) | HEMOCARD, HEMOGLOBIN C ASSAY | Isolab, Inc. | Jan 27, 1994 | SESE |

## Top Applicants

- Isolab, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/MLL](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/MLL)

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