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

    MEDIA FOR GAMETE PREPARATION AND EMBRYO CULTURE

    K Number: K002836 · Decision Oct 3, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    258
    Applicant Total
    6
    Review Days
    21

    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
    MEDIA FOR GAMETE PREPARATION AND EMBRYO CULTURE
    K Number
    K002836
    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
    September 12, 2000
    Decision Date
    October 3, 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

    Similar 510(k) Clearances

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

    Ultra-Fast Warm

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Fast Warm - NX

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA])

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Ultra-Fast Vitri; Ultra-Fast Warm

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicin

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology
    View all

    Other Clearances by Sage Biopharma

    K Number Device Name
    K003734 SERUM PROTEIN SUBSTITUTE
    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