Browse hierarchy: [Hematology (HE)](/submissions/HE) → [Subpart H — Hematology Kits and Packages](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages) → [21 CFR 864.7440](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/864.7440) → JBD — System, Analysis, Electrophoretic Hemoglobin # JBD · System, Analysis, Electrophoretic Hemoglobin _Hematology · 21 CFR 864.7440 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBD ## Overview - **Product Code:** JBD - **Device Name:** System, Analysis, Electrophoretic Hemoglobin - **Regulation:** [21 CFR 864.7440](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/864.7440) - **Device Class:** 2 - **Review Panel:** [Hematology](/submissions/HE) - **3rd-party reviewable:** yes ## Identification An electrophoretic hemoglobin analysis system is a device that electrophoretically separates and identifies normal and abnormal hemoglobin types as an aid in the diagnosis of anemia or erythrocytosis (increased total red cell mass) due to a hemoglobin abnormality. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 26) Showing 20 most recent of 26 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K053571](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBD/K053571.md) | MICROGEL ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM, MICROGEL ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM | Interlab S.R.L. | Jun 30, 2006 | SESE | | [K032862](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBD/K032862.md) | INTERLAB ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM | Interlab S.R.L. | Feb 3, 2004 | SESE | | [K992199](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBD/K992199.md) | ACID HEMOGLOBIN KIT | Helena Laboratories | Sep 21, 1999 | SESE | | [K991362](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBD/K991362.md) | HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15 HEMOGLOBIN(E), ACID(E) HEMOGLOBIN(E), MINI ACID(E) HEMO) | Morax | Jun 21, 1999 | SESE | | [K982426](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBD/K982426.md) | SPIFE ALKALINE HEMOGLOBIN | Helena Laboratories | Dec 17, 1998 | SESE | | [K931503](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBD/K931503.md) | REP HEMOGLOBIN IEF KITS (CAT. NO. 3250) | Helena Laboratories | Aug 16, 1993 | SESE | | [K931465](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBD/K931465.md) | REP ALKALINE HB-15 #3196,-8 #3197,-4 3198 | Helena Laboratories | Jul 6, 1993 | SESE | | [K901143](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBD/K901143.md) | REP HEMOGLOBIN IEF KITS (CAT. NO. 3250) | Helena Laboratories | May 23, 1990 | SESE | | [K830804](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBD/K830804.md) | LABILE REMOVING HEMOLYZING REAGENT | Corning Medical & Scientific | May 4, 1983 | SESE | | [K820518](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBD/K820518.md) | GELMAN GLYCO-PHORE BUFFER | Gelman Sciences, Inc. | Apr 9, 1982 | SESE | | [K813395](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBD/K813395.md) | CELLULOSE ACETATE-CITRATE AGAR HEMOGLO | Helena Laboratories | Dec 31, 1981 | SESE | | [K810919](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBD/K810919.md) | HEMOGLOBIN ELECTROPHORESIS CONTROL | Isolab, Inc. | Apr 23, 1981 | SESE | | [K810047](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBD/K810047.md) | AUTOPHOR 128 | Gelman Sciences, Inc. | Feb 5, 1981 | SESE | | [K802884](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBD/K802884.md) | CORNING NORMAL GLYCOSYLATED HEMOGLOBIN | Corning Medical & Scientific | Dec 22, 1980 | SESE | | [K802821](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBD/K802821.md) | PARAGON HEMOGLOBIN ELECTRO. REAG. KIT | Beckman Instruments, Inc. | Dec 11, 1980 | SESE | | [K800856](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBD/K800856.md) | A,FDA2 LYOPHILIZED HEMO CONTROL | Helena Laboratories | Apr 29, 1980 | SESE | | [K800855](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBD/K800855.md) | A,FSC LYOPHILIZED HEMO CONTROL | Helena Laboratories | Apr 29, 1980 | SESE | | [K800854](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBD/K800854.md) | A,A2 LYOPHILIZED HEMO CONTROL | Helena Laboratories | Apr 29, 1980 | SESE | | [K800853](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBD/K800853.md) | A,SA2 LYOPHILIZED HEMO CONTROL | Helena Laboratories | Apr 29, 1980 | SESE | | [K791290](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBD/K791290.md) | BECKMAN B-4 TEB BUFFER KIT | Beckman Instruments, Inc. | Aug 3, 1979 | SESE | ## Top Applicants - Helena Laboratories — 11 clearances - Corning Medical & Scientific — 3 clearances - Beckman Instruments, Inc. — 2 clearances - Electrophoresis Corp. of America — 2 clearances - Gelman Sciences, Inc. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBD](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBD) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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