BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    REFRACTOMETRIC, TOTAL PROTEIN

    K Number: K933218 · Decision Feb 17, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    269
    Registration Numbers
    269
    Same Product Code
    492
    Applicant Total
    12
    Review Days
    231

    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
    REFRACTOMETRIC, TOTAL PROTEIN
    K Number
    K933218
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Pyramid Biological Corp.
    Date Received
    July 1, 1993
    Decision Date
    February 17, 1994
    Product Code
    JJX
    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
    JJX Single (Specified) Analyte Controls (Assayed And Unassayed)

    Similar 510(k) Clearances

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

    Beta-CrossLaps CalCheck 5

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Elecsys CYFRA 21-1 CalCheck 5

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Multichem A1c

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Audit MicroControls Linearity DROP LQ Blood Glucose

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    LIAISON CMV IgM Serum Control Set

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    LIAISON EBV IgM Serum Control Set

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry
    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
    K953826 ENZYME LINKED UMMINOABSORBENT 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
    Search all 12 clearances from Pyramid Biological Corp. →