BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    COXSACKIE VIRUS B1-B6 CF ANTIGENS

    K Number: K921618 · Decision Jun 29, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    1
    Applicant Total
    5
    Review Days
    84

    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
    COXSACKIE VIRUS B1-B6 CF ANTIGENS
    K Number
    K921618
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3145
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Virion (U.S.), Inc.
    Date Received
    April 6, 1992
    Decision Date
    June 29, 1992
    Product Code
    GNG
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GNG Antigens, Cf (Including Cf Control), Coxsackievirus A 1-24, B 1-6

    Similar 510(k) Clearances

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

    COXSACKIE B SERIES CF ANTIGENS

    FDA 510(k)
    FDA Class 1 ·Microbiology
    View all

    Other Clearances by Virion (U.S.), Inc.

    K Number Device Name
    K933251 EPSTEIN-BARR VIRUS COMBI TEST, EBV COMBI TEST
    K905306 MUMPS COMPLEMENT-FIXATION (C.F.) ANTIGEN
    K905385 P.I.V. COMPLEMENT-FIXATION (C.F.) ANTIGEN
    K864981 TOXOPLASMA GONDII