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

    ASTRA

    K Number: K811381 · Decision Aug 13, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    27
    Applicant Total
    9
    Review Days
    90

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    Basic Information

    Device Name
    ASTRA
    K Number
    K811381
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1160
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Chem-Elec, Inc.
    Date Received
    May 15, 1981
    Decision Date
    August 13, 1981
    Product Code
    JFL
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JFL Ph Rate Measurement, Carbon-Dioxide

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    Other Clearances by Chem-Elec, Inc.

    K Number Device Name
    K943503 CHEMCARD GLUCOSE TEST
    K864159 SOLID PHASE DETER SERUM CHOLESTEROL FR WHOLE BLOOD
    K811165 GLUCOSE OXIDASE RATE REAGENT
    K811406 CREATININE RATE REAGENT KIT
    K811319 CHLORIDE REAGENT KIT
    K811193 BUN RATE REAGENT
    K811310 SODIUM/POTASSIUM REAGENT KITS
    K811701 CHLORIDE/CARBON DIOXIDE RATE REAGENT