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

    TANDEM PAP KIT - (PARTS I & II)

    K Number: K811959 · Decision Sep 1, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    44
    Applicant Total
    63
    Review Days
    54

    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
    TANDEM PAP KIT - (PARTS I & II)
    K Number
    K811959
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1020
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Hybritech, Inc.
    Date Received
    July 9, 1981
    Decision Date
    September 1, 1981
    Product Code
    JFH
    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
    JFH Acid Phosphatase (Prostatic), Tartrate Inhibited

    Similar 510(k) Clearances

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

    IMMULITE 2000 PAP, MODELS L2KPA2, L2KPA6

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    UBI MAGIWEL PAP (PROSTATIC ACID PHOSPHATASE) EIA QUANTITATVE

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PROSTATIC ACID PHOSPHATASE REAGENT TEST/PROSTATIC ACID PHOSPHATASE REAGENT KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    IMMULITE PAP

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    IMX PAP

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNO

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry
    View all

    Other Clearances by Hybritech, Inc.

    K Number Device Name
    K972666 TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAY
    K961573 TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY
    K930810 TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY
    K922754 TANDEM-E IGE II CALIBRATION VERIFICATION SET
    K921745 HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNO
    K921252 TANDEM-E FERRITIN CALIBRATION VERIFICATION CONROL
    K920556 TANDEM-E HCG CALIBRATION VERIFICATION CONTROL SET
    K921763 TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAY
    K912439 TANDEM-E TSH CALIBRATION VERIFICATION CONTROL SET
    K911417 ICON STREP B IMMUNOENZYMETRIC ASSAY
    Search all 63 clearances from Hybritech, Inc. →