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

    PERSONALLAB AUTOMATED MICROPLATE ANALYZER

    K Number: K971761 · Decision Jul 22, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    174
    Registration Numbers
    174
    Same Product Code
    207
    Applicant Total
    4
    Review Days
    71

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    Basic Information

    Device Name
    PERSONALLAB AUTOMATED MICROPLATE ANALYZER
    K Number
    K971761
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2160
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biochem Immunosystems (U.S.), Inc.
    Date Received
    May 12, 1997
    Decision Date
    July 22, 1997
    Product Code
    JJE
    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
    JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

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    Other Clearances by Biochem Immunosystems (U.S.), Inc.

    K Number Device Name
    K960072 SPIRIT HEMATOLOGY SYSTEM MODEL LE, CP, & AX
    K954065 BIODATA SR1 FAH-HCG ENZYME IMMUNOASSAY KIT
    K955102 BIODATA TESTOSTERONE MAIA KIT