BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇭 Switzerland

    Clearblue® Early Digital Pregnancy Test

    K Number: K200913 · Decision Aug 13, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    225
    Applicant Total
    4
    Review Days
    494

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    Basic Information

    Device Name
    Clearblue® Early Digital Pregnancy Test
    K Number
    K200913
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1155
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Spd Swiss Precision Diagnostics GmbH
    Date Received
    April 6, 2020
    Decision Date
    August 13, 2021
    Product Code
    LCX
    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
    LCX Kit, Test, Pregnancy, Hcg, Over The Counter

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    Other Clearances by Spd Swiss Precision Diagnostics GmbH

    K Number Device Name
    K240025 Clearblue® Early Detection Pregnancy Test
    K213379 Clearblue ® Early Pregnancy Test
    K210341 One Step Pregnancy Test