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

    RAMP HERPES SIMPLEX VIRUS (HSV) (CCT)

    K Number: K874863 · Decision Feb 16, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    33
    Applicant Total
    14
    Review Days
    83

    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
    RAMP HERPES SIMPLEX VIRUS (HSV) (CCT)
    K Number
    K874863
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3305
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Monoclonal Antibodies, Inc.
    Date Received
    November 25, 1987
    Decision Date
    February 16, 1988
    Product Code
    GQN
    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
    GQN Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2

    Similar 510(k) Clearances

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

    DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION AND TYPING KIT, MODEL 01-090000

    FDA 510(k)
    FDA Class 2 ·Microbiology

    DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION KIT, MODEL 01-080000

    FDA 510(k)
    FDA Class 2 ·Microbiology

    LIGHT DIAGNOSTICS SIMULFLUOR HSV 1/2 IMMUNOFLUORECENCE ASSAY

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ELVIS HSV ID/TYPING TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    HSV-2 ANTIGEN CONTROL SLIDES

    FDA 510(k)
    FDA Class 2 ·Microbiology

    HSV-1 ANTIGEN CONTROL SLIDES

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

    Other Clearances by Monoclonal Antibodies, Inc.

    K Number Device Name
    K871726 OVUQUICK SELF-TEST (OVUQUICK; RAMP LH ASSAY)
    K863744 HCG CONTROL KIT
    K860924 RAMP PROGESTURINE PDG ASSAY--48 TEST KIT
    K854611 RAMP URINE HCG ASSAY
    K850730 MODEL SERUM HCG ASSAY
    K850480 OVU STICK SELF-TEST -MODIFICATION
    K843284 OVUSTICK SELF-TEST
    K840738 PLUS URINE HCG ASSAY
    K840412 OVU STICK URINE HLH KIT
    K833504 PREGNASTICK URINE HCG KIT
    Search all 14 clearances from Monoclonal Antibodies, Inc. →