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

    CEDIA(R) GENTAMICIN ASSAY

    K Number: K913470 · Decision Sep 27, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    36
    Applicant Total
    107
    Review Days
    53

    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
    CEDIA(R) GENTAMICIN ASSAY
    K Number
    K913470
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3450
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Microgenics Corp.
    Date Received
    August 5, 1991
    Decision Date
    September 27, 1991
    Product Code
    LCD
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LCD Enzyme Immunoassay, Gentamicin

    Similar 510(k) Clearances

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

    ARCHITECT iGentamicin

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ARCHITECT IGENTAMICIN REAGENTS; ARCHITECT IGENTAMICIN CALIBRATORS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    MULTIGENT GENTAMICIN

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    VITROS CHEMISTRY PRODUCTS GENT, TOBRA & VANC REAGENTS; VITROS CHEMISTYR PRODUCTS CALIBRATOR KITS 11, 13 & 14; VITROS CHE

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ROCHE ONLINE GENTAMICIN

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    RANDOX GENTAMICIN

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology
    View all

    Other Clearances by Microgenics Corp.

    K Number Device Name
    K122766 THERMO SCIENTIFIC QMS EVEROLIMUS ASSAY
    K123343 THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORS
    K123271 ABBOTT PHENOBARBITAL ASSAY
    K110616 THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PRO
    K101742 THERMO SCIENTIFIC CEDIA COCAINE OFT ASSAY
    K101744 THERMO SCIENTIFIC CEDIA CANNABINOIDS OFT ASSAY
    K101752 THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORS
    K101746 THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAY
    K101753 THERMO SCIENTIFIC CEDIA METHAMPHETAMINE OFT ASSAY
    K101754 THERMO SCIENTIFIC CEDIA OPIATE OFT ASSAY
    Search all 107 clearances from Microgenics Corp. →