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