BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ASTORIA-PACIFIC SPOTCHECK G6PD KIT 50 HR, MODEL 80-3000-13K

    K Number: K990957 · Decision May 11, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    1
    Applicant Total
    9
    Review Days
    50

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    Basic Information

    Device Name
    ASTORIA-PACIFIC SPOTCHECK G6PD KIT 50 HR, MODEL 80-3000-13K
    K Number
    K990957
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7360
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Astoria-Pacific, Inc.
    Date Received
    March 22, 1999
    Decision Date
    May 11, 1999
    Product Code
    JBL
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JBL Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Quantitative

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (JBL), ordered by most recent decision date.

    DEHYDROGENOSE, GLUCOSE PHOSPHATE

    FDA 510(k)
    FDA Class 2 ·Hematology
    View all

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    K090940 SPOTCHECK BLOOD SPOT CONTROL, ASSAYED
    K080294 ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE MICROPLATE REAGENT KIT
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