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

    ENZYME LINKED UMMINOABSORBENT ASSAY, RUBELLA

    K Number: K953826 · Decision Dec 14, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    1
    Applicant Total
    12
    Review Days
    121

    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
    ENZYME LINKED UMMINOABSORBENT ASSAY, RUBELLA
    K Number
    K953826
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3510
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Pyramid Biological Corp.
    Date Received
    August 15, 1995
    Decision Date
    December 14, 1995
    Product Code
    GOM
    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
    GOM Antisera, Cf, Rubella

    Similar 510(k) Clearances

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

    ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA

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

    Other Clearances by Pyramid Biological Corp.

    K Number Device Name
    K964675 H.PYLORI CONTROLS
    K962399 HEPATITIS NEGATIVE CONTROL
    K961317 SYPHILIS IGM HUMAN SERUM CONTROLS
    K960493 SYPHILIS IGG HUMAN SERUM CONTROLS
    K954515 ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA
    K952818 ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII
    K951800 CMV IGG HUMAN SERUM CONTROLS
    K952254 ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS
    K944515 SERUM PROTEIN CONTROLS
    K933218 REFRACTOMETRIC, TOTAL PROTEIN
    Search all 12 clearances from Pyramid Biological Corp. →