BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇮 Finland

    RUBALEX

    K Number: K852788 · Decision Mar 12, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    12
    Applicant Total
    21
    Review Days
    254

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    Basic Information

    Device Name
    RUBALEX
    K Number
    K852788
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3510
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Orion Corp.
    Date Received
    July 1, 1985
    Decision Date
    March 12, 1986
    Product Code
    LQN
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LQN Latex Agglutination Assay, Rubella

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    Other Clearances by Orion Corp.

    K Number Device Name
    K912391 RUBALEX, MODIFICATION
    K901637 RESUBMITTED MODIFIED RUBALEX
    K884650 RESUBMITTED SCANORA
    K890199 DENTOCULT SM-STRIP MUTANS
    K881506 MAMEX DC MAG MG12
    K881505 MAMEX DC MG11
    K874040 MAMEX DC S SL10/MG14
    K872744 MODIFIED CHLAMYSET ANTIGEN
    K872301 DENTOCULT-SM CULTURE-PADDLE
    K864457 CHLAMYSET ANTIBODY EIA
    Search all 21 clearances from Orion Corp. →