GKR · System, Hemoglobin, Automated
Hematology · 21 CFR 864.5620 · Class 2
Overview
| Product Code | GKR |
|---|---|
| Device Name | System, Hemoglobin, Automated |
| Regulation | 21 CFR 864.5620 |
| Device Class | Class 2 |
| Review Panel | Hematology |
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 | HemoCue Hb 301 System | Hemocue AB | Aug 4, 2020 | SESE |
| K200909 | Hemo Control (optional Add Pack Hemo Control DM) | Ekf-Diagnostic GmbH | Jun 12, 2020 | SESE |
| K181751 | HemoCue Hb 801 System | Hemocue AB | Feb 1, 2019 | SESE |
| K182298 | hemochroma PLUS System | Immunostics Inc., | Nov 16, 2018 | SESE |
| K172173 | DiaSpect Tm, DiaSpect Tm Cuvettes | Ekf-Diagnostic GmbH | Apr 6, 2018 | SESE |
| K163465 | hemochroma PLUS System | Immunostics Inc., | Sep 8, 2017 | SESE |
| K122553 | MISSION PLUS HB HEMOGLOBIN TESTING SYSTEM | ACON Laboratories, Inc. | Aug 5, 2013 | SESE |
| K121752 | AVIE TOTAL HB TEST SYSTEM | Mec Dynamics Corp | Jan 7, 2013 | SESE |
| K110393 | EKF- DIAGNOSTIC HEMO_CONTROL HEMOGLOBIN MEASUREMENT SYSTEM; EKF-DIAGNOSTIC HEMOGLOBIN MICROCUVETTES (MODIFIED CURVETTE W | Ekf-Diagnostic GmbH | Mar 4, 2011 | SESE |
| K090093 | STANBIO LABORATORY HEMOPOINT H2 DM HEMOGLOBIN MEASUREMENT SYSTEM | Stanbio Laboratory | Jun 10, 2009 | SESE |
| K081719 | STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM | Stanbio Laboratory | Jul 18, 2008 | SESE |
| K061047 | HEMOCUE HB 301 ANALYZER, MODEL 121804 AND MICROCUVETTES, MODEL 111801 | Hemocue AB | Jun 8, 2006 | SESE |
| K041234 | HEMOCUE HEMOGLOBIN 201DM ANALYZING SYSTEM | Hemocue, Inc. | Jun 10, 2004 | SESE |
| K032482 | STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM | Stanbio Laboratory | Oct 24, 2003 | SESE |
| K031898 | EKF DIAGNOSTIC HEMO CONTROL HEMOGLOBIN MEASUREMENT SYSTEM | Ekf Diagnostic GmbH | Sep 24, 2003 | SESE |
| K032203 | HEMOCUE HEMOGLOBIN 201 + SYSTEM ARTICLE 121704 | Hemocue, Inc. | Aug 25, 2003 | SESE |
| K023561 | ITC HGB PRO PROFESSIONAL HEMOGLOBIN TESTING SYSTEM | International Technidyne Corp. | Jan 31, 2003 | SESE |
| K020710 | BIOTEST HEMOGLOBIN MEASURING SYSTEM | Biotest Medizintechnik GmbH | Aug 14, 2002 | SESE |
| K020616 | BAYER RAPIDPOINT 405 SYSTEM | Bayer Diagnostics Corp. | Jul 17, 2002 | SESE |
| K961312 | 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
