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

    SERUM PROTEIN SUBSTITUTE

    K Number: K003734 · Decision Dec 21, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    258
    Applicant Total
    6
    Review Days
    17

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    Basic Information

    Device Name
    SERUM PROTEIN SUBSTITUTE
    K Number
    K003734
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    884.6180
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Sage Biopharma
    Date Received
    December 4, 2000
    Decision Date
    December 21, 2000
    Product Code
    MQL
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MQL Media, Reproductive

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    Other Clearances by Sage Biopharma

    K Number Device Name
    K002836 MEDIA FOR GAMETE PREPARATION AND EMBRYO CULTURE
    K991396 WATER FOR TISSUE CULTURE, MODELS 500 L & 1.5 L
    K991393 HYALURONIDASE, 80 U/ML
    K991390 1.5 M PROPANEDIOL FREEZING MEDIUM, 1.5 PROPANEDIOL 0.1 SUCROSE FREEZING MEDIUM, 9% GLYCEROL, 0.2 M SUCROSE FREEZING MEDI
    K991378 PHOSPHATE BUFFERED SALINE (PBS), PHOSPHATE BUFFERED SALINE WITH CALCIUM, MAGNESIUM, GLUCOSE, PYRUVATE AND PHENOL RED