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

    AMERLITE CK-MB ASSAY

    K Number: K912766 · Decision Jul 17, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    39
    Applicant Total
    94
    Review Days
    23

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    Basic Information

    Device Name
    AMERLITE CK-MB ASSAY
    K Number
    K912766
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1215
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Amersham Corp.
    Date Received
    June 24, 1991
    Decision Date
    July 17, 1991
    Product Code
    JHY
    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
    JHY Colorimetric Method, Cpk Or Isoenzymes

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    Other Clearances by Amersham Corp.

    K Number Device Name
    K914135 AMERLITE(TM) PROLACTIN-30 ASSAY, LAN.0086/2086
    K912733 AMERLEX-M SPECIFIC ESTROL(UNCONJUGATED) RIA KIT
    K904666 AMERLITE TSH-60 ASSAY PRODUCT CODE: LAN. 0008/2008
    K902760 AMERSHAM TSH CONTROL SERA
    K901854 GADOLINIUM-153 BONE DENSITOMETER (GDC.10411/10412)
    K901857 GADOLINIUM-153 BONE DENSITOMETER (GDC.10413)
    K901848 GADOLINIUM-153 BONE DENSITOMETER SOURCES
    K901832 GADOLINIUM-153 BONE DENSITOMETER SOURCES GDC.10415
    K896270 AMERLITE ESTRADIOL-60 ASSAY LAN.0081/2081
    K895872 LAN.0800Q/2800Q
    Search all 94 clearances from Amersham Corp. →