Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Biological StainsCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cell And Tissue Culture ProductsCFR Sub-Part
- Subpart C—Clinical Laboratory InstrumentsCFR Sub-Part
- Subpart E—Specimen Preparation ReagentsCFR Sub-Part
- Subpart F—Automated and Semi-Automated Hematology DevicesCFR Sub-Part
- GKFInstrument, Hematocrit, Automated2Product Code
- GKHApparatus, Automated Blood Cell Diluting1Product Code
- GKJSpinner, Slide, Automated1Product Code
- GKLCounter, Cell, Automated (Particle Counter)2Product Code
- GKNTimer, Clot, Automated2Product Code
- GIZPlasma, Control, Normal2Product Code
- GKBDevice, Automated Sedimentation Rate1Product Code
- GGCControl, Plasma, Abnormal2Product Code
- GGNPlasma, Coagulation Control2Product Code
- GHKCentrifuge, Microsedimentation1Product Code
- GHRReagent, Platelet Aggregation2Product Code
- GIEFibrometer2Product Code
- GKPInstrument, Coagulation, Automated2Product Code
- GKRSystem, Hemoglobin, Automated2Product Code
- K201217HemoCue Hb 301 System2Cleared 510(K)
- K200909Hemo Control (optional Add Pack Hemo Control DM)2Cleared 510(K)
- K181751HemoCue Hb 801 System2Cleared 510(K)
- K182298hemochroma PLUS System2Cleared 510(K)
- K172173DiaSpect Tm, DiaSpect Tm Cuvettes2Cleared 510(K)
- K163465hemochroma PLUS System2Cleared 510(K)
- K122553MISSION PLUS HB HEMOGLOBIN TESTING SYSTEM2Cleared 510(K)
- K121752AVIE TOTAL HB TEST SYSTEM2Cleared 510(K)
- K110393EKF- DIAGNOSTIC HEMO_CONTROL HEMOGLOBIN MEASUREMENT SYSTEM; EKF-DIAGNOSTIC HEMOGLOBIN MICROCUVETTES (MODIFIED CURVETTE W2Cleared 510(K)
- K090093STANBIO LABORATORY HEMOPOINT H2 DM HEMOGLOBIN MEASUREMENT SYSTEM2Cleared 510(K)
- K081719STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM2Cleared 510(K)
- K061047HEMOCUE HB 301 ANALYZER, MODEL 121804 AND MICROCUVETTES, MODEL 1118012Cleared 510(K)
- K041234HEMOCUE HEMOGLOBIN 201DM ANALYZING SYSTEM2Cleared 510(K)
- K032482STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM2Cleared 510(K)
- K031898EKF DIAGNOSTIC HEMO CONTROL HEMOGLOBIN MEASUREMENT SYSTEM2Cleared 510(K)
- K032203HEMOCUE HEMOGLOBIN 201 + SYSTEM ARTICLE 1217042Cleared 510(K)
- K023561ITC HGB PRO PROFESSIONAL HEMOGLOBIN TESTING SYSTEM2Cleared 510(K)
- K020710BIOTEST HEMOGLOBIN MEASURING SYSTEM2Cleared 510(K)
- K020616BAYER RAPIDPOINT 405 SYSTEM2Cleared 510(K)
- K961312HEMOCUE B-HEMOGLOBIN SYSTEM2Cleared 510(K)
- K945677IL682, CO-OXIMETER2Cleared 510(K)
- K954018AVL OMNI ANALYZER2Cleared 510(K)
- K910745HEMOGLOBIN REAGENT2Cleared 510(K)
- K880353CIBA CORNING MODEL 280 PH/BLOOD GAS SYSTEM2Cleared 510(K)
- K870210CLEARVIEW CW-102Cleared 510(K)
- K865055DR.BRUNO LANGE MINI-HBA1 PHOTOMETER2Cleared 510(K)
- K850094LASER-GLOBIN POWDER2Cleared 510(K)
- K850096LASER-GLOBIN2Cleared 510(K)
- K841057HEMOGLOBIN REAGENT SET2Cleared 510(K)
- K832020HEMOCUE PHOTOMETER TECHNICAL MANUAL2Cleared 510(K)
- K831618HEMOGLOBIN REAGENT2Cleared 510(K)
- K812127KING DIAGNOSTICS HEMOGLOBIN TEST2Cleared 510(K)
- K803016HELENA HEMESPEC II TOTAL HEMOGLOBIN MET.2Cleared 510(K)
- K803015HEMESPEC II2Cleared 510(K)
- K802266HGB3 (1:251)2Cleared 510(K)
- K790030FLUID, RHEMOX-HB LYSING2Cleared 510(K)
- K781361HEMOGLOBINOMETER MODEL 720 B2Cleared 510(K)
- K780829SYSING AND HEMOGLOBIN REAGENT2Cleared 510(K)
- K771789BLANKING SOLUTION HGB2Cleared 510(K)
- GKXInstrument, Automated Platelet Counting2Product Code
- GKZCounter, Differential Cell2Product Code
- JBTTimer, Coagulation2Product Code
- JBWRed-Cell Indices, Measured2Product Code
- JOXAnalyzer, Heparin, Automated2Product Code
- JOYDevice, Automated Cell-Locating2Product Code
- JOZSystem, Automated Platelet Aggregation2Product Code
- JPASystem, Multipurpose For In Vitro Coagulation Studies2Product Code
- JPJRed-Cell Indices, Calculated2Product Code
- JWODevice, Blood Volume Measuring2Product Code
- KQGInstrument, Coagulation2Product Code
- KQHRed-Cell Indices2Product Code
- LGPAssay, Alpha-2-Antiplasmin2Product Code
- LKMCounter, Urine Particle2Product Code
- LLGKit, Igg, Platelet Associated2Product Code
- MAMDna-Probe, B And T Lymphocyte2Product Code
- OBW11-Dehydro Thromboxane B2 Kit, Urinary2Product Code
- OYEFlow Cytometric Reagents And Accessories.2Product Code
- PMGAutomated Multicolor Fluorescent Imaging Cytometric Analysis System2Product Code
- POVSemen Analysis Device2Product Code
- QFRCoagulation System For The Measurement Of Whole Blood Viscoelastic Properties2Product Code
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Immunological Test SystemsCFR Sub-Part
- Subpart G—Manual Hematology DevicesCFR Sub-Part
- Subpart G—Tumor Associated Antigen immunological Test SystemsCFR Sub-Part
- Subpart H—Hematology Kits and PackagesCFR Sub-Part
- Subpart I—Hematology ReagentsCFR Sub-Part
- Subpart J—Products Used In Establishments That Manufacture Blood and Blood ProductsCFR Sub-Part
- Subpart K—Products Used In Establishments That Manufacture Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)CFR Sub-Part
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
HEMOCUE HB 301 ANALYZER, MODEL 121804 AND MICROCUVETTES, MODEL 111801
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K061047
- 510(k) Type
- Traditional
- Applicant
- Hemocue AB
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 6/8/2006
- Days to Decision
- 55 days
- Submission Type
- Summary