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

    SAFE AT-HOME TEST KIT FOR MONITORING HEMOGLOBIN ALC

    K Number: K991850 · Decision Nov 26, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    65
    Registration Numbers
    65
    Same Product Code
    248
    Applicant Total
    6
    Review Days
    178

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    Basic Information

    Device Name
    SAFE AT-HOME TEST KIT FOR MONITORING HEMOGLOBIN ALC
    K Number
    K991850
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7470
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biosafe Laboratories, Inc.
    Date Received
    June 1, 1999
    Decision Date
    November 26, 1999
    Product Code
    LCP
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LCP Assay, Glycosylated Hemoglobin

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    Other Clearances by Biosafe Laboratories, Inc.

    K Number Device Name
    K042379 ANEMIAPRO SELF-SCREENER
    K012221 SAFE AT HOME CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM
    K011970 BIOSAFE CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM
    K011525 SAFE AT HOME TSH (THYROID STIMULATING HORMONE BLOOD COLLECTION AND TRANSPORT SYSTEM)
    K003752 BIOSAFE CAPILLARY BLOOD TRANSPORT SYSTEM FOR TESTING THYROID STIMULATING HORMONE (TSH)