BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇦 Canada

    MEASLES-COMPLEMENT FIX ANTIGEN & NEGATIVE CLT

    K Number: K852932 · Decision Nov 12, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    1
    Applicant Total
    7
    Review Days
    126

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    Basic Information

    Device Name
    MEASLES-COMPLEMENT FIX ANTIGEN & NEGATIVE CLT
    K Number
    K852932
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3520
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Microbix Biosystems, Inc.
    Date Received
    July 9, 1985
    Decision Date
    November 12, 1985
    Product Code
    GRF
    Advisory Committee
    Microbiology
    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
    GRF Antiserum, Cf, Rubeola

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (GRF), ordered by most recent decision date.

    THREE SPIKE CUP

    FDA 510(k)
    FDA Class 1 ·Microbiology
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    Other Clearances by Microbix Biosystems, Inc.

    K Number Device Name
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    K894262 RUBELLA ANTIGEN AND CONTROL ANTIGEN
    K852930 VARICELLA-ZOSTER-COMPLE FIX ANTIGEN AND NEG CONTRO
    K852931 HERPES HOMINUS I-COMPLE FIX ANTIGEN & NEGATIVE CLT
    K852929 CMV-COMPLEMENT FIXATION ANTIGEN AND NEGATIVE CONTR
    K852933 MYCOPLASMA SPP SEROLOGICAL REAGENTS