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

    Dimension EXL LOCI BRAHMS Procalcitonin (PCT)

    K Number: K220262 · Decision Aug 26, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    7
    Applicant Total
    152
    Review Days
    207

    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
    Dimension EXL LOCI BRAHMS Procalcitonin (PCT)
    K Number
    K220262
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3215
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Siemens Healthcare Diagnostics, Inc.
    Date Received
    January 31, 2022
    Decision Date
    August 26, 2022
    Product Code
    PRI
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

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

    Product Code Device Name
    PRI Procalcitonin Assay

    Similar 510(k) Clearances

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

    Elecsys BRAHMS PCT

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Elecsys BRAHMS PCT

    FDA 510(k)
    FDA Class 2 ·Microbiology

    LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS PCT II GEN Verifiers

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Lumipulse G B•R•A•H•M•S PCT Immunoreaction Cartridges, Lumipulse G B•R•A•H•M•S PCT Calibrators set

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT Controls

    FDA 510(k)
    FDA Class 2 ·Microbiology

    B R A H M S PCT sensitive KRYPTOR

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

    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. →