BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    TYROSINE 50-HOUR REAGENT KIT

    K Number: K970093 · Decision Mar 19, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    9
    Review Days
    433

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    Basic Information

    Device Name
    TYROSINE 50-HOUR REAGENT KIT
    K Number
    K970093
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1730
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Astoria-Pacific, Inc.
    Date Received
    January 10, 1997
    Decision Date
    March 19, 1998
    Product Code
    CDR
    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
    CDR 1-Nitroso-2-Naphthol (Fluorometric), Free Tyrosine

    Other Clearances by Astoria-Pacific, Inc.

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    K101392 NEOPAC SOFTWARE, 3007 DIGITAL PHOTOMETER/FLUOROMETER MODEL NA, 307 AND 350D
    K090940 SPOTCHECK BLOOD SPOT CONTROL, ASSAYED
    K080294 ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE MICROPLATE REAGENT KIT
    K010844 ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE KIT, 50 HOUR, PART NO. 80-8000-13K
    K990957 ASTORIA-PACIFIC SPOTCHECK G6PD KIT 50 HR, MODEL 80-3000-13K
    K970277 URIDYLTRANSFERASE KIT, 50 HOUR (80-4000-13K)