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

    RIALYZE HPL (RIA)

    K Number: K770659 · Decision May 20, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    10
    Applicant Total
    158
    Review Days
    43

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    Basic Information

    Device Name
    RIALYZE HPL (RIA)
    K Number
    K770659
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1585
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Miles Laboratories, Inc.
    Date Received
    April 7, 1977
    Decision Date
    May 20, 1977
    Product Code
    JMF
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JMF Radioimmunoassay, Human Placental Lactogen

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    Other Clearances by Miles Laboratories, Inc.

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    K871835 GLUCOMETER QC BLOOD METER, AMES GLUCO SYSTEM PRINT
    K872120 SERALYZER III BLOOD CHEMISTRY ANALYZER
    K873304 CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES)
    K872634 CUTTER PUREFLO PLUS IV FILTER
    K870214 MODIFIED SALTEX REAGENT STRIPS
    K870752 SERALYZER LDH/TOTAL BILIRUBIN/TRIGLYCERIDES STRIPS
    K865053 SERA-TEK MICROSOMAL ANTIBODY TEST
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