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510(k) Data Aggregation

    K Number
    K111211
    Device Name
    CELL-DYN 22 PLUS CONTROL
    Manufacturer
    Streck
    Date Cleared
    2011-12-22

    (237 days)

    Product Code
    GLQ
    Regulation Number
    864.8625
    Why did this record match?
    Product Code :

    GLQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CELL-DYN 22 Plus Control is an assayed hematology control for evaluating the accuracy and precision of the CELL-DYN Emerald 22 system. Assayed parameters include: WBC (108/L), RBC (1013L), HGB (g/dL), HCT (%), MCV (fL), MCH (pg), MCHC (g/dL), RDW (%), PLT (10°/L), MPV (iL), NEU (%), NEU (10°/L), LYM (%), LYM (10°/L), MON (10°/L), EOS (%), EOS (10°/L), BAS (%), BAS (10°/L)
    Device Description
    CELL-DYN 22 Plus Control is an in-vitro diagnostic product that contains stabilized human red blood cells, human, mammalian or simulated white blood cells and a platelet component in a preservative medium. The product is packaged in polypropylene plastic vials containing 2.5ml. The closures are polypropylene screw caps with polyethylene liners. There are three different levels (low, normal and high). The vials will be packaged in a six (6) or twelve (12) welled vacuum formed "clam-shell" container with the package insert / assay sheet. The product must be stored at 2 - 10° C.
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    K Number
    K110718
    Device Name
    CELL-CHEX WITH CPPD CRYSTALS
    Manufacturer
    Streck
    Date Cleared
    2011-05-26

    (72 days)

    Product Code
    GLQ
    Regulation Number
    864.8625
    Why did this record match?
    Product Code :

    GLQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Cell-Chex™ with CPPD Crystals is an assayed control intended for monitoring total cell counts performed manually using a hemocytometer to validate quantitation of red and white blood cells in patient cerebrospinal fluid and body fluid samples including pleural, pericardial, peritoneal and synovial fluid. Level 1 contains calcium pyrophosphate dihydrate (CPPD) Crystals which can be used to monitor the presence of crystals in synovial fluid. Cell-Chex™ with CPPD Crystals is also intended for monitoring white blood cell differentiation (Mononuclear, Polymorphonuclear; Neutrophils, Eosinophils, Basophils, Lymphocytes and Monocytes) in body fluid samples performed using Cytospin® smears.
    Device Description
    Cell-Chex™ with CPPD Crystals is a stabilized suspension of human red blood cells, human white blood cells and calcium pyrophosphate dihydrate (CPPD) Crystals (Level 1 only) in a preservative medium. The product is packaged in glass vials containing 2.0ml. The closures are polypropylene screw caps with polvethylene liners. There are two different levels. Level 1 contains a low cell count and CPPD crystals, and Level 2 contains a high cell count and no crystals. The vials will be packaged in a six (6) or twelve (12) welled vacuum formed clamshell container with the package insert / assay sheet. The product must be stored at 2 - 10°C.
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    K Number
    K101335
    Device Name
    CELL-CHEX
    Manufacturer
    Streck
    Date Cleared
    2010-08-23

    (103 days)

    Product Code
    GLQ, GLO
    Regulation Number
    864.8625
    Why did this record match?
    Product Code :

    GLQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Cell-Chex is an assayed control intended for monitoring total cell counts performed manually using a hemocytometer to validate quantitation of red and white blood cells in patient cerebrospinal fluid and body fluid samples including pleural, pericardial, peritoneal and synovial fluid. Level 1 contains monosodium urate crystals which can be used to monitor the presence of crystals in synovial fluid. Cell-Chex is also intended for monitoring white blood cell differentiation (Mononuclear, Polymorphonuclear: Neutrophils, Eosinophils, Basophils, Lymphocytes and Monocytes) in body fluid samples performed using Cytospin® smears.
    Device Description
    Cell-Chex is a stabilized suspension of human red blood cells, human white blood cells and monosodium urate crystals (Level 1 only) in a preservative medium. The product is packaged in glass vials containing 2.0ml. The closures are polypropylene screw caps with polyethylene liners. There are two different levels. Level 1 contains a low cell count and monosodium urate crystals, and Level 2 contains a high cell count and no crystals. The vials will be packaged in a six (6) or twelve (12) welled vacuum formed "clam-shell" container with the package insert / assay sheet. The product must be stored at 2 - 10° C.
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    K Number
    K090137
    Device Name
    STAK-CHEX PLUS RETICS
    Manufacturer
    Streck
    Date Cleared
    2009-03-18

    (56 days)

    Product Code
    GLQ
    Regulation Number
    864.8625
    Why did this record match?
    Product Code :

    GLQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    STaK-Chex Plus Retics is an assayed whole blood control for evaluating the accuracy and precision of automated, semi-automated and manual procedures that measure blood cell parameters.
    Device Description
    STaK-Chex Plus Retics is a stabilized suspension of human red blood cells, a nucleated red blood cell analog, a white blood cell component consisting of human analogs and a platelet component consisting of a non-human analog in a preservative medium. The product is packaged in plastic vials containing 5ml. The closures are polypropylene screw caps with polyethylene liners. There are three different levels (low, normal and high). The vials will be packaged in a six (6) or twelve (12) welled vacuum formed "clam-shell" container with the package insert / assay sheet. The product must be stored at 2 - 10° C.
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    K Number
    K000945
    Device Name
    PARA 12 PLUS RETICS
    Manufacturer
    STRECK LABORATORIES, INC.
    Date Cleared
    2000-04-18

    (26 days)

    Product Code
    GLQ
    Regulation Number
    864.8625
    Why did this record match?
    Product Code :

    GLQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K994388
    Device Name
    XE CHECK
    Manufacturer
    STRECK LABORATORIES, INC.
    Date Cleared
    2000-01-14

    (17 days)

    Product Code
    GLQ, GLO, JPK
    Regulation Number
    864.8625
    Why did this record match?
    Product Code :

    GLQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    XE Check is intended to be used as a control for evaluating complete blood cell count (CBC), white cell five-part differential, and reticulocyte percentage on Sysmex XE – 2100 series hematology instruments. The device will consist of three levels: Abnormal Low (characterized by low CBC, high reticulocyte %), Normal (normal CBC, normal reticulocyte %), and Abnormal High (high CBC, low reticulocyte %).
    Device Description
    XE Check is a suspension of stabilized human red blood cells, human white cells, simulated human platelets, and simulated human reticulocytes packaged in glass vials containing 4.6 mL volumes. Closures are injection molded polypropylene screw-top caps. The vials are packaged in polystyrene jars.
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    K Number
    K992887
    Device Name
    STAK-CHEX PLUS RETICS
    Manufacturer
    STRECK LABORATORIES, INC.
    Date Cleared
    1999-11-22

    (87 days)

    Product Code
    GLQ
    Regulation Number
    864.8625
    Why did this record match?
    Product Code :

    GLQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    STaK-Chex Plus Retics is intended to be used as a control for complete blood cell count (CBC), white cell five-part differential, and reticulocyte parameters on Beckman/Coulter GenS series hematology instruments.
    Device Description
    STaK-Chex Plus Retics is a suspension of stabilized human red blood cells, human white cells, simulated human platelets, and simulated human reticulocytes packaged in glass vials containing 4.5 mL volumes. Closures are injection molded polypropylene screw-top caps. The vials are packaged in polystyrene jars.
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