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

    Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP)

    K Number: K222116 · Decision Jul 13, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    241
    Applicant Total
    152
    Review Days
    360

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    Basic Information

    Device Name
    Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP)
    K Number
    K222116
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1690
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Siemens Healthcare Diagnostics, Inc.
    Date Received
    July 18, 2022
    Decision Date
    July 13, 2023
    Product Code
    JLW
    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
    JLW Radioimmunoassay, Thyroid-Stimulating Hormone

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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. →