GKR — System, Hemoglobin, Automated Class II
FDA product code GKR covers "System, Hemoglobin, Automated", a Class II medical device regulated under 21 CFR 864.5620. Submissions are reviewed by the Hematology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GKR
- Device Class
- Class II
- Regulation Number
- 864.5620
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K201217 | hemocue | HemoCue Hb 301 System | August 4, 2020 |
| K200909 | ekf-diagnostic | Hemo Control (optional Add Pack Hemo Control DM) | June 12, 2020 |
| K181751 | hemocue | HemoCue Hb 801 System | February 1, 2019 |
| K182298 | immunostics inc | hemochroma PLUS System | November 16, 2018 |
| K172173 | ekf-diagnostic | DiaSpect Tm, DiaSpect Tm Cuvettes | April 6, 2018 |
| K163465 | immunostics inc | hemochroma PLUS System | September 8, 2017 |
| K122553 | acon laboratories | MISSION PLUS HB HEMOGLOBIN TESTING SYSTEM | August 5, 2013 |
| K121752 | mec dynamics | AVIE TOTAL HB TEST SYSTEM | January 7, 2013 |
| K110393 | ekf-diagnostic | EKF- DIAGNOSTIC HEMO_CONTROL HEMOGLOBIN MEASUREMENT SYSTEM; EKF-DIAGNOSTIC HEMOG | March 4, 2011 |
| K090093 | stanbio laboratory | STANBIO LABORATORY HEMOPOINT H2 DM HEMOGLOBIN MEASUREMENT SYSTEM | June 10, 2009 |
| K081719 | stanbio laboratory | STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM | July 18, 2008 |
| K061047 | hemocue | HEMOCUE HB 301 ANALYZER, MODEL 121804 AND MICROCUVETTES, MODEL 111801 | June 8, 2006 |
| K041234 | hemocue | HEMOCUE HEMOGLOBIN 201DM ANALYZING SYSTEM | June 10, 2004 |
| K032482 | stanbio laboratory | STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM | October 24, 2003 |
| K031898 | ekf diagnostic | EKF DIAGNOSTIC HEMO CONTROL HEMOGLOBIN MEASUREMENT SYSTEM | September 24, 2003 |
| K032203 | hemocue | HEMOCUE HEMOGLOBIN 201 + SYSTEM ARTICLE 121704 | August 25, 2003 |
| K023561 | international technidyne | ITC HGB PRO PROFESSIONAL HEMOGLOBIN TESTING SYSTEM | January 31, 2003 |
| K020710 | biotest medizintechnik | BIOTEST HEMOGLOBIN MEASURING SYSTEM | August 14, 2002 |
| K020616 | bayer diagnostics | BAYER RAPIDPOINT 405 SYSTEM | July 17, 2002 |
| K961312 | hemocue | HEMOCUE B-HEMOGLOBIN SYSTEM | September 24, 1996 |