FDA Product Code
FDA Product Code GKR — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.5620
510(k) Clearances — 39 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K201217 | HemoCue Hb 301 System | Hemocue AB | 2020-08-04 | Traditional | PDF ↗ |
| K200909 | Hemo Control (optional Add Pack Hemo Control DM) | Ekf-Diagnostic GmbH | 2020-06-12 | Special | PDF ↗ |
| K181751 | HemoCue Hb 801 System | Hemocue AB | 2019-02-01 | Traditional | PDF ↗ |
| K182298 | hemochroma PLUS System | Immunostics Inc., | 2018-11-16 | Traditional | PDF ↗ |
| K172173 | DiaSpect Tm, DiaSpect Tm Cuvettes | Ekf-Diagnostic GmbH | 2018-04-06 | Traditional | PDF ↗ |
| K163465 | hemochroma PLUS System | Immunostics Inc., | 2017-09-08 | Traditional | PDF ↗ |
| K122553 | MISSION PLUS HB HEMOGLOBIN TESTING SYSTEM | ACON Laboratories, Inc. | 2013-08-05 | Traditional | PDF ↗ |
| K121752 | AVIE TOTAL HB TEST SYSTEM | Mec Dynamics Corp | 2013-01-07 | Traditional | PDF ↗ |
| K110393 | EKF- DIAGNOSTIC HEMO_CONTROL HEMOGLOBIN MEASUREMENT SYSTEM; EKF-DIAGNOSTIC HEMOGLOBIN MICROCUVETTES (MODIFIED CURVETTE W | Ekf-Diagnostic GmbH | 2011-03-04 | Special | PDF ↗ |
| K090093 | STANBIO LABORATORY HEMOPOINT H2 DM HEMOGLOBIN MEASUREMENT SYSTEM | Stanbio Laboratory | 2009-06-10 | Special | PDF ↗ |
| K081719 | STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM | Stanbio Laboratory | 2008-07-18 | Special | PDF ↗ |
| K061047 | HEMOCUE HB 301 ANALYZER, MODEL 121804 AND MICROCUVETTES, MODEL 111801 | Hemocue AB | 2006-06-08 | Traditional | PDF ↗ |
| K041234 | HEMOCUE HEMOGLOBIN 201DM ANALYZING SYSTEM | Hemocue, Inc. | 2004-06-10 | Special | PDF ↗ |
| K032482 | STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM | Stanbio Laboratory | 2003-10-24 | Traditional | PDF ↗ |
| K031898 | EKF DIAGNOSTIC HEMO CONTROL HEMOGLOBIN MEASUREMENT SYSTEM | Ekf Diagnostic GmbH | 2003-09-24 | Traditional | PDF ↗ |
| K032203 | HEMOCUE HEMOGLOBIN 201 + SYSTEM ARTICLE 121704 | Hemocue, Inc. | 2003-08-25 | Special | PDF ↗ |
| K023561 | ITC HGB PRO PROFESSIONAL HEMOGLOBIN TESTING SYSTEM | International Technidyne Corp. | 2003-01-31 | Traditional | PDF ↗ |
| K020710 | BIOTEST HEMOGLOBIN MEASURING SYSTEM | Biotest Medizintechnik GmbH | 2002-08-14 | Abbreviated | PDF ↗ |
| K020616 | BAYER RAPIDPOINT 405 SYSTEM | Bayer Diagnostics Corp. | 2002-07-17 | Traditional | PDF ↗ |
| K961312 | HEMOCUE B-HEMOGLOBIN SYSTEM | Hemocue, Inc. | 1996-09-24 | Traditional | PDF ↗ |
| K945677 | IL682, CO-OXIMETER | Instrumentation Laboratory CO | 1995-10-20 | Traditional | PDF ↗ |
| K954018 | AVL OMNI ANALYZER | Avl Scientific Corp. | 1995-10-05 | Traditional | PDF ↗ |
| K910745 | HEMOGLOBIN REAGENT | Toa Medical Electronics USA, Inc. | 1991-07-11 | Traditional | PDF ↗ |
| K880353 | CIBA CORNING MODEL 280 PH/BLOOD GAS SYSTEM | Ciba Corning Diagnostics Corp. | 1988-06-15 | Traditional | PDF ↗ |
| K870210 | CLEARVIEW CW-10 | Clearview Instruments, Inc. | 1987-04-28 | Traditional | PDF ↗ |
| K865055 | DR.BRUNO LANGE MINI-HBA1 PHOTOMETER | Diversa Corp. | 1987-03-19 | Traditional | PDF ↗ |
| K850094 | LASER-GLOBIN POWDER | Hematology Marketing Assoc. | 1985-03-29 | Traditional | PDF ↗ |
| K850096 | LASER-GLOBIN | Hematology Marketing Assoc. | 1985-03-29 | Traditional | PDF ↗ |
| K841057 | HEMOGLOBIN REAGENT SET | Medical Specialties, Inc. | 1984-03-23 | Traditional | PDF ↗ |
| K832020 | HEMOCUE PHOTOMETER TECHNICAL MANUAL | Aktiebolaget Leo Diagnostics | 1983-10-28 | Traditional | PDF ↗ |
| K831618 | HEMOGLOBIN REAGENT | Omega Medical Diagnostics | 1983-06-16 | Traditional | PDF ↗ |
| K812127 | KING DIAGNOSTICS HEMOGLOBIN TEST | King Diagnostics, Inc. | 1981-08-25 | Traditional | PDF ↗ |
| K803015 | HEMESPEC II | Helena Laboratories | 1980-12-30 | Traditional | PDF ↗ |
| K803016 | HELENA HEMESPEC II TOTAL HEMOGLOBIN MET. | Helena Laboratories | 1980-12-30 | Traditional | PDF ↗ |
| K802266 | HGB3 (1:251) | R&D Systems, Inc. | 1980-10-23 | Traditional | PDF ↗ |
| K790030 | FLUID, RHEMOX-HB LYSING | Sysmex Corp. | 1979-02-08 | Traditional | PDF ↗ |
| K781361 | HEMOGLOBINOMETER MODEL 720 B | Innovative Medical Systems, Inc. | 1978-09-14 | Traditional | PDF ↗ |
| K780829 | SYSING AND HEMOGLOBIN REAGENT | Harleco | 1978-06-22 | Traditional | PDF ↗ |
| K771789 | BLANKING SOLUTION HGB | J.T. Baker Chemical Co. | 1977-10-07 | Traditional | PDF ↗ |
Product code GKR · Class II · Hematology. Data: openFDA.