BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇩🇰 Denmark

    SERUM CROSSLAPS ONE STEP ELISA

    K Number: K990843 · Decision Jul 9, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    20
    Applicant Total
    2
    Review Days
    116

    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
    SERUM CROSSLAPS ONE STEP ELISA
    K Number
    K990843
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1400
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Osteometer Biotech A/S
    Date Received
    March 15, 1999
    Decision Date
    July 9, 1999
    Product Code
    JMM
    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
    JMM Column Chromatography & Color Development, Hydroxyproline

    Similar 510(k) Clearances

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

    OSTEOMARK NTX POINT OF CARE PRESCRIPTION HOME USE

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ELECSYS SERUM B-CROSSLAPS/SERUM IMMUNOASSAY

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    OSTEOMARK NTX POC

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    OSTEOMARK NTX SERUM EIA

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    VITROS IMMUNODIAGNOSTIC PRODUCTS: NTX CALIBRATORS, NTX REAGENT PACK, NTX CONTROLS

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    CROSSLAPS ELISA

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry
    View all

    Other Clearances by Osteometer Biotech A/S

    K Number Device Name
    K003609 N-MID OSTEOCALCIN ONE STEP ELISA MODEL 30SC4000