Product code GKR
- Device name
- System, Hemoglobin, Automated
- Medical specialty
- Hematology
- Device class
- 2
- Regulation number
- 864.5620
- Review panel
- HE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K201217 | HemoCue Hb 301 System | Hemocue AB | 2020-08-04 |
| K200909 | Hemo Control (optional Add Pack Hemo Control DM) | Ekf-Diagnostic GmbH | 2020-06-12 |
| K181751 | HemoCue Hb 801 System | Hemocue AB | 2019-02-01 |
| K182298 | hemochroma PLUS System | Immunostics Inc., | 2018-11-16 |
| K172173 | DiaSpect Tm, DiaSpect Tm Cuvettes | Ekf-Diagnostic GmbH | 2018-04-06 |
| K163465 | hemochroma PLUS System | Immunostics Inc., | 2017-09-08 |
| K122553 | MISSION PLUS HB HEMOGLOBIN TESTING SYSTEM | ACON Laboratories, Inc. | 2013-08-05 |
| K121752 | AVIE TOTAL HB TEST SYSTEM | Mec Dynamics Corp | 2013-01-07 |
| K110393 | EKF- DIAGNOSTIC HEMO_CONTROL HEMOGLOBIN MEASUREMENT SYSTEM; EKF-DIAGNOSTIC HEMOGLOBIN MICROCUVETTES (MODIFIED CURVETTE W | Ekf-Diagnostic GmbH | 2011-03-04 |
| K090093 | STANBIO LABORATORY HEMOPOINT H2 DM HEMOGLOBIN MEASUREMENT SYSTEM | Stanbio Laboratory | 2009-06-10 |
| K081719 | STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM | Stanbio Laboratory | 2008-07-18 |
| K061047 | HEMOCUE HB 301 ANALYZER, MODEL 121804 AND MICROCUVETTES, MODEL 111801 | Hemocue AB | 2006-06-08 |
| K041234 | HEMOCUE HEMOGLOBIN 201DM ANALYZING SYSTEM | Hemocue, Inc. | 2004-06-10 |
| K032482 | STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM | Stanbio Laboratory | 2003-10-24 |
| K031898 | EKF DIAGNOSTIC HEMO CONTROL HEMOGLOBIN MEASUREMENT SYSTEM | Ekf Diagnostic GmbH | 2003-09-24 |
| K032203 | HEMOCUE HEMOGLOBIN 201 + SYSTEM ARTICLE 121704 | Hemocue, Inc. | 2003-08-25 |
| K023561 | ITC HGB PRO PROFESSIONAL HEMOGLOBIN TESTING SYSTEM | International Technidyne Corp. | 2003-01-31 |
| K020710 | BIOTEST HEMOGLOBIN MEASURING SYSTEM | Biotest Medizintechnik GmbH | 2002-08-14 |
| K020616 | BAYER RAPIDPOINT 405 SYSTEM | Bayer Diagnostics Corp. | 2002-07-17 |
| K961312 | HEMOCUE B-HEMOGLOBIN SYSTEM | Hemocue, Inc. | 1996-09-24 |
| K945677 | IL682, CO-OXIMETER | Instrumentation Laboratory CO | 1995-10-20 |
| K954018 | AVL OMNI ANALYZER | Avl Scientific Corp. | 1995-10-05 |
| K910745 | HEMOGLOBIN REAGENT | Toa Medical Electronics USA, Inc. | 1991-07-11 |
| K880353 | CIBA CORNING MODEL 280 PH/BLOOD GAS SYSTEM | Ciba Corning Diagnostics Corp. | 1988-06-15 |
| K870210 | CLEARVIEW CW-10 | Clearview Instruments, Inc. | 1987-04-28 |
| K865055 | DR.BRUNO LANGE MINI-HBA1 PHOTOMETER | Diversa Corp. | 1987-03-19 |
| K850094 | LASER-GLOBIN POWDER | Hematology Marketing Assoc. | 1985-03-29 |
| K850096 | LASER-GLOBIN | Hematology Marketing Assoc. | 1985-03-29 |
| K841057 | HEMOGLOBIN REAGENT SET | Medical Specialties, Inc. | 1984-03-23 |
| K832020 | HEMOCUE PHOTOMETER TECHNICAL MANUAL | Aktiebolaget Leo Diagnostics | 1983-10-28 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 17311091118148 | HemoCue® Hb 301 Microcuvettes | Hemocue AB | 2022-10-28 |
| 17311091118124 | HemoCue® Hb 301 Microcuvettes | Hemocue AB | 2022-08-30 |
| 14048534001967 | DiaSpect Tm Cuvettes | EKF-diagnostic GmbH | 2021-03-11 |
| 17311091118094 | HemoCue® Hb 301 Microcuvettes | Hemocue AB | 2020-09-04 |
| 10612479234120 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2018-08-21 |
| 10612479234144 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2018-08-21 |
| 10612479234090 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2018-08-21 |
| 17311091117318 | HemoCue® Hb 201 Microcuvettes | Hemocue AB | 2018-05-25 |
| 17311091117325 | HemoCue® Hb 201 Microcuvettes | Hemocue AB | 2018-05-25 |
| 17311091118070 | HemoCue® Hb 301 Microcuvettes | Hemocue AB | 2016-12-01 |
| 00385480322041 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480278072 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480289535 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480289542 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480278034 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480248198 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480243278 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480239622 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480230230 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480225076 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480215206 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480215190 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480215138 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480214971 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480214902 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480205191 | NOVA/STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 17311091118018 | HemoCue® Hb 301 Microcuvettes | Hemocue AB | 2016-05-31 |
| 17311091117165 | HemoCue® Hb 201 Microcuvettes | Hemocue AB | 2016-05-31 |
| 17311091117158 | HemoCue® Hb 201 Microcuvettes | Hemocue AB | 2016-05-31 |
| 17311091103021 | HemoCue® Plasma/Low Hb Microcuvettes | Hemocue AB | 2016-05-27 |