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

    BINAXNOW G6PD TEST

    K Number: K080003 · Decision Oct 23, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    4
    Applicant Total
    30
    Review Days
    295

    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
    BINAXNOW G6PD TEST
    K Number
    K080003
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7360
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Binax, Inc.
    Date Received
    January 2, 2008
    Decision Date
    October 23, 2008
    Product Code
    JBF
    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
    JBF Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening

    Similar 510(k) Clearances

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

    FINDER G6PD

    FDA 510(k)
    FDA Class 2 ·Hematology

    BinaxNOW G6PD Test

    FDA 510(k)
    FDA Class 2 ·Hematology

    G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE

    FDA 510(k)
    FDA Class 2 ·Hematology

    GLUCOSE-6-PHOSPHATE DEHYDROGENASE DEFICIENCY SCREENING TEST KIT NO. 202-A

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

    Other Clearances by Binax, Inc.

    K Number Device Name
    K090301 BINAXNOW PBP2A TEST, MODEL 890-000
    K091766 CLEARVIEW EXACT PBP2A TEST, MODEL 891-000
    K090964 BINAXNOX STAPHYLOCOCCUS AUREUS TEST
    K091489 CLEARVIEW ADVANCED STREP A , MODEL 737-430
    K083744 BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010
    K092223 MODIFICATION TO: BINAXNOW INFLUENZA A & B TEST
    K062109 BINAXNOW INFLUENZA A & B TEST
    K053126 BINAXNOW INFLUENZA A & B TEST
    K041049 BINAXNOW INFLUENZA A & B TEST
    K032166 BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL SWAB ACCESSORY PACK, MODEL 400-065
    Search all 30 clearances from Binax, Inc. →