← [Hematology](/submissions/HE) · Product Code MLL # 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 - **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. ## Cleared Devices (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 --- **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) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite as:** FDA Device Explorer (Innolitics), https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/MLL