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

    SPIFE A1AT kit

    K Number: K213396 · Decision Oct 13, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    1
    Applicant Total
    2
    Review Days
    360

    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
    SPIFE A1AT kit
    K Number
    K213396
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5130
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Helena Laboratories, Corp.
    Date Received
    October 18, 2021
    Decision Date
    October 13, 2022
    Product Code
    OBZ
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    OBZ Alpha-1-Antitrypsin Kit, Qualitative Phenotype

    Similar 510(k) Clearances

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

    HYDRAGEL 18 A1AT ISOFOCUSING KIT (PN 4356)

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

    Other Clearances by Helena Laboratories, Corp.

    K Number Device Name
    K192931 V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control