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

    SPQ TEST SYSTEM II FOR FIB (SERUM PROTEIN QUANTI.)

    K Number: K900939 · Decision May 16, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    27
    Applicant Total
    58
    Review Days
    77

    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
    SPQ TEST SYSTEM II FOR FIB (SERUM PROTEIN QUANTI.)
    K Number
    K900939
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7340
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Incstar Corp.
    Date Received
    February 28, 1990
    Decision Date
    May 16, 1990
    Product Code
    KQJ
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KQJ System, Fibrinogen Determination

    Similar 510(k) Clearances

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

    HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL

    FDA 510(k)
    FDA Class 2 ·Hematology

    HEMOSIL FIBRINOGEN-C

    FDA 510(k)
    FDA Class 2 ·Hematology

    DADE THROMBIN REAGENT

    FDA 510(k)
    FDA Class 2 ·Hematology

    SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A)

    FDA 510(k)
    FDA Class 2 ·Hematology

    FIF TM

    FDA 510(k)
    FDA Class 2 ·Hematology

    N-ASSAY TIA FIBRINOGEN TEST KIT

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

    Other Clearances by Incstar Corp.

    K Number Device Name
    K963289 INCSTAR TOXOPLASMA IGM CAPTURE ELISA ASSAY
    K963296 INCSTAR TOXOPLASMA IGG ALISA ASSAY (CAT.#7565)
    K963297 INCSTAR TOXOPLASMA IGG FAST ELISA ASSAY (CAT.#7560)
    K960367 INCSTAR RUBELLA IGG ELISA ASSAY
    K960358 INCSTAR RUBELLA IGG FAST ELISA ASSAY
    K960434 INCSTAR CYTOMEGALOVIRUS IGM CAPTURE ELISA ASSAY MODEL 8530
    K953567 INCSTAR 25-HYDROXYVITMIN D 1251 RIA
    K955362 INCSTAR HSV I/II IGG FAST ELISA ASSAY
    K955363 INCSTAR HSZ I/II IGG ELISA ASSAY
    K955361 INCSTAR CYTOMEGALOVIRUS IGG ELISA ASSAY
    Search all 58 clearances from Incstar Corp. →