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

    RUBALEX, MODIFICATION

    K Number: K912391 · Decision May 4, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    12
    Applicant Total
    21
    Review Days
    346

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    RUBALEX, MODIFICATION
    K Number
    K912391
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3510
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Orion Corp.
    Date Received
    May 24, 1991
    Decision Date
    May 4, 1992
    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

    Similar 510(k) Clearances

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

    RUBELLACOL

    FDA 510(k)
    FDA Class 2 ·Microbiology

    COPALIS TORC TOTAL ANTIBODY ASSAY

    FDA 510(k)
    FDA Class 2 ·Microbiology

    COPALIS ONE IMMUNOASSAY SYSTEM/TOXOPLASMA GONDII/RUBELLA/CMV TOTAL ANTIBODY ASSAYS

    FDA 510(k)
    FDA Class 2 ·Microbiology

    MUREX RUB-EX

    FDA 510(k)
    FDA Class 2 ·Microbiology

    COLORSLIDER RUBELLA

    FDA 510(k)
    FDA Class 2 ·Microbiology

    RESUBMITTED MODIFIED RUBALEX

    FDA 510(k)
    FDA Class 2 ·Microbiology
    View all

    Other Clearances by Orion Corp.

    K Number Device Name
    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
    K872058 ORICULT-N CULTURE-PADDLE
    Search all 21 clearances from Orion Corp. →