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

    Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc)

    K Number: K222439 · Decision Aug 8, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    30
    Applicant Total
    152
    Review Days
    361

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    Basic Information

    Device Name
    Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc)
    K Number
    K222439
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3950
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Siemens Healthcare Diagnostics, Inc.
    Date Received
    August 12, 2022
    Decision Date
    August 8, 2023
    Product Code
    LEH
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LEH Radioimmunoassay, Vancomycin

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    Other Clearances by Siemens Healthcare Diagnostics, Inc.

    K Number Device Name
    K251998 Atellica CH Diazo Total Bilirubin (D_TBil)
    K251543 Atellica® IM TSH3-Ultra II (TSH3ULII)
    K251630 Atellica IM Total PSA II (tPSAII)
    K250816 ADVIA Centaur Anti-Thyroglobulin II (aTgII)
    K250250 ADVIA Centaur Anti-Thyroid Peroxidase II
    K242981 Atellica IM Thyroglobulin (Tg)
    K242685 Atellica® CH Creatinine_3 (Crea3)
    K241800 Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC)
    K241165 Atellica® IM High-Sensitivity Troponin I (TnIH)
    K233050 ADVIA Centaur® TSH3-Ultra II (TSH3ULII)
    Search all 152 clearances from Siemens Healthcare Diagnostics, Inc. →