Browse hierarchy: [Hematology (HE)](/submissions/HE) → [Subpart F — Automated and Semi-Automated Hematology Devices](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices) → [21 CFR 864.5620](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/864.5620) → GKR — System, Hemoglobin, Automated # GKR · System, Hemoglobin, Automated _Hematology · 21 CFR 864.5620 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKR ## Overview - **Product Code:** GKR - **Device Name:** System, Hemoglobin, Automated - **Regulation:** [21 CFR 864.5620](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/864.5620) - **Device Class:** 2 - **Review Panel:** [Hematology](/submissions/HE) ## Identification An automated hemoglobin system is a fully automated or semi-automated device which may or may not be part of a larger system. The generic type of device consists of the reagents, calibrators, controls, and instrumentation used to determine the hemoglobin content of human blood. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 39) Showing 20 most recent of 39 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K201217](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKR/K201217.md) | HemoCue Hb 301 System | Hemocue AB | Aug 4, 2020 | SESE | | [K200909](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKR/K200909.md) | Hemo Control (optional Add Pack Hemo Control DM) | Ekf-Diagnostic GmbH | Jun 12, 2020 | SESE | | [K181751](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKR/K181751.md) | HemoCue Hb 801 System | Hemocue AB | Feb 1, 2019 | SESE | | [K182298](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKR/K182298.md) | hemochroma PLUS System | Immunostics Inc., | Nov 16, 2018 | SESE | | [K172173](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKR/K172173.md) | DiaSpect Tm, DiaSpect Tm Cuvettes | Ekf-Diagnostic GmbH | Apr 6, 2018 | SESE | | [K163465](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKR/K163465.md) | hemochroma PLUS System | Immunostics Inc., | Sep 8, 2017 | SESE | | [K122553](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKR/K122553.md) | MISSION PLUS HB HEMOGLOBIN TESTING SYSTEM | ACON Laboratories, Inc. | Aug 5, 2013 | SESE | | [K121752](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKR/K121752.md) | AVIE TOTAL HB TEST SYSTEM | Mec Dynamics Corp | Jan 7, 2013 | SESE | | [K110393](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKR/K110393.md) | EKF- DIAGNOSTIC HEMO_CONTROL HEMOGLOBIN MEASUREMENT SYSTEM; EKF-DIAGNOSTIC HEMOGLOBIN MICROCUVETTES (MODIFIED CURVETTE W | Ekf-Diagnostic GmbH | Mar 4, 2011 | SESE | | [K090093](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKR/K090093.md) | STANBIO LABORATORY HEMOPOINT H2 DM HEMOGLOBIN MEASUREMENT SYSTEM | Stanbio Laboratory | Jun 10, 2009 | SESE | | [K081719](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKR/K081719.md) | STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM | Stanbio Laboratory | Jul 18, 2008 | SESE | | [K061047](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKR/K061047.md) | HEMOCUE HB 301 ANALYZER, MODEL 121804 AND MICROCUVETTES, MODEL 111801 | Hemocue AB | Jun 8, 2006 | SESE | | [K041234](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKR/K041234.md) | HEMOCUE HEMOGLOBIN 201DM ANALYZING SYSTEM | Hemocue, Inc. | Jun 10, 2004 | SESE | | [K032482](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKR/K032482.md) | STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM | Stanbio Laboratory | Oct 24, 2003 | SESE | | [K031898](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKR/K031898.md) | EKF DIAGNOSTIC HEMO CONTROL HEMOGLOBIN MEASUREMENT SYSTEM | Ekf Diagnostic GmbH | Sep 24, 2003 | SESE | | [K032203](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKR/K032203.md) | HEMOCUE HEMOGLOBIN 201 + SYSTEM ARTICLE 121704 | Hemocue, Inc. | Aug 25, 2003 | SESE | | [K023561](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKR/K023561.md) | ITC HGB PRO PROFESSIONAL HEMOGLOBIN TESTING SYSTEM | International Technidyne Corp. | Jan 31, 2003 | SESE | | [K020710](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKR/K020710.md) | BIOTEST HEMOGLOBIN MEASURING SYSTEM | Biotest Medizintechnik GmbH | Aug 14, 2002 | SESE | | [K020616](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKR/K020616.md) | BAYER RAPIDPOINT 405 SYSTEM | Bayer Diagnostics Corp. | Jul 17, 2002 | SESE | | [K961312](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKR/K961312.md) | HEMOCUE B-HEMOGLOBIN SYSTEM | Hemocue, Inc. | Sep 24, 1996 | SESE | ## Top Applicants - Ekf-Diagnostic GmbH — 3 clearances - Hemocue AB — 3 clearances - Hemocue, Inc. — 3 clearances - Stanbio Laboratory — 3 clearances - Helena Laboratories — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKR](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKR) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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