Browse hierarchy: [Hematology (HE)](/submissions/HE) → [Subpart I — Hematology Reagents](/submissions/HE/subpart-i%E2%80%94hematology-reagents) → [21 CFR 864.8540](/submissions/HE/subpart-i%E2%80%94hematology-reagents/864.8540) → GGK — Products, Red-Cell Lysing Products # GGK · Products, Red-Cell Lysing Products _Hematology · 21 CFR 864.8540 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/GGK ## Overview - **Product Code:** GGK - **Device Name:** Products, Red-Cell Lysing Products - **Regulation:** [21 CFR 864.8540](/submissions/HE/subpart-i%E2%80%94hematology-reagents/864.8540) - **Device Class:** 1 - **Review Panel:** [Hematology](/submissions/HE) ## Identification A red cell lysing reagent is a device used to lyse (destroy) red blood cells for hemoglobin determinations or aid in the counting of white blood cells. ## Classification Rationale Class I (general controls). This 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 (20 of 29) Showing 20 most recent of 29 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K883836](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/GGK/K883836.md) | COULTER CLONE QUICK STAIN WHOLE BLOOD LYSE-II | Coulter Immunology | Nov 30, 1988 | SESE | | [K883991](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/GGK/K883991.md) | KVM HEMOGLOBIN LYSING REAGENT | Kvm Technologies, Inc. | Oct 12, 1988 | SESE | | [K874054](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/GGK/K874054.md) | FISHER DIAGNOSTICS HEMATALL III LAS REAGENT | Fisher Scientific Co., LLC | Oct 20, 1987 | SESE | | [K873348](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/GGK/K873348.md) | CELL-DYN DIFF SCREEN, AUTO. & SEMI AUTO. LYTIC AG. | Abbott Diagnostics | Sep 9, 1987 | SESE | | [K863114](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/GGK/K863114.md) | PIASTRINIT | J. D. Assoc. | Nov 6, 1986 | SESE | | [K863503](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/GGK/K863503.md) | HEMOLYSE | Reagent Laboratory, Inc. | Oct 3, 1986 | SESE | | [K850944](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/GGK/K850944.md) | NSI LYSING-D REAGENT -4000 ML | Nobel Scientific Industries, Inc. | Mar 29, 1985 | SESE | | [K850097](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/GGK/K850097.md) | LASER-LYSE | Hematology Marketing Assoc. | Mar 29, 1985 | SESE | | [K842938](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/GGK/K842938.md) | ACETIC ACID 1% V/V | E K Ind., Inc. | Sep 14, 1984 | SESE | | [K842937](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/GGK/K842937.md) | ACETIC ACID 2% V/V | E K Ind., Inc. | Sep 12, 1984 | SESE | | [K842936](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/GGK/K842936.md) | ACETIC ACID, 3% V/V | E K Ind., Inc. | Sep 12, 1984 | SESE | | [K842935](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/GGK/K842935.md) | ACETIC ACID, 5% V/V | E K Ind., Inc. | Sep 12, 1984 | SESE | | [K842069](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/GGK/K842069.md) | IDL-LYSING REAGENT | Interscience Diagnostics, Inc. | Jul 2, 1984 | SESE | | [K841800](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/GGK/K841800.md) | LYSING & HEMOGLOBIN REAGENT | Reagent Laboratory, Inc. | May 31, 1984 | SESE | | [K840289](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/GGK/K840289.md) | LYSE-TEC | Medilab Corp. | Mar 5, 1984 | SESE | | [K834527](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/GGK/K834527.md) | THROMBO PLUS | W. Sarstedt, Inc. | Jan 30, 1984 | SESE | | [K833444](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/GGK/K833444.md) | LYSING & HEMOGLOBIN S-REAGENT J & S | Jasins & Sayles Associates, Inc. | Nov 3, 1983 | SESE | | [K832182](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/GGK/K832182.md) | LYSING REAGENT | Omega Medical Diagnostics | Aug 12, 1983 | SESE | | [K830186](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/GGK/K830186.md) | LYSIS + | Hematology Marketing Assoc. | Feb 28, 1983 | SESE | | [K822324](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/GGK/K822324.md) | RED CELL LYSING REAGENT 78N 1915-1 | Interscience, Inc. | Nov 8, 1982 | SESE | ## Top Applicants - E K Ind., Inc. — 4 clearances - Connecticut Diagnostics, Ltd. — 2 clearances - Hematology Marketing Assoc. — 2 clearances - Reagent Laboratory, Inc. — 2 clearances - Abbott Diagnostics — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/GGK](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/GGK) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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