BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇦 Canada

    MYCOPLASMA SPP SEROLOGICAL REAGENTS

    K Number: K852933 · Decision Aug 1, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    4
    Applicant Total
    7
    Review Days
    23

    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
    MYCOPLASMA SPP SEROLOGICAL REAGENTS
    K Number
    K852933
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3375
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Microbix Biosystems, Inc.
    Date Received
    July 9, 1985
    Decision Date
    August 1, 1985
    Product Code
    GSB
    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
    GSB Antigens, Cf, All, Mycoplasma Spp.

    Similar 510(k) Clearances

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

    MYCOPLASMA PNEUMONIAE

    FDA 510(k)
    FDA Class 1 ·Microbiology

    MYCOPLASMA PNEUMONIAE CF ANTIGEN

    FDA 510(k)
    FDA Class 1 ·Microbiology

    SERA-TEK MYCOPLASMA ANTIBODY TEST

    FDA 510(k)
    FDA Class 1 ·Microbiology

    MYCOPLASMA PNEUMONIAE ANTIGEN & CONTROL

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

    Other Clearances by Microbix Biosystems, Inc.

    K Number Device Name
    K894261 TOXOPLASMA GONDII-CF ANTIGEN AND CONTROL ANTIGEN
    K894262 RUBELLA ANTIGEN AND CONTROL ANTIGEN
    K852932 MEASLES-COMPLEMENT FIX ANTIGEN & NEGATIVE CLT
    K852930 VARICELLA-ZOSTER-COMPLE FIX ANTIGEN AND NEG CONTRO
    K852931 HERPES HOMINUS I-COMPLE FIX ANTIGEN & NEGATIVE CLT
    K852929 CMV-COMPLEMENT FIXATION ANTIGEN AND NEGATIVE CONTR