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

    QUANTA LITE MITOCHONDRIA M2 ELISA

    K Number: K933180 · Decision Aug 5, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30
    Same Product Code
    113
    Applicant Total
    138
    Review Days
    36

    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
    QUANTA LITE MITOCHONDRIA M2 ELISA
    K Number
    K933180
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5510
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Inova Diagnostics, Inc.
    Date Received
    June 30, 1993
    Decision Date
    August 5, 1993
    Product Code
    DGC
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DGC Ige, Antigen, Antiserum, Control

    Similar 510(k) Clearances

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

    Kenota 1 Total IgE; Kenota 1 (instrument)

    FDA 510(k)
    FDA Class 2 ·Immunology

    Quantia IgE

    FDA 510(k)
    FDA Class 2 ·Immunology

    Total Immunoglobulin E (IgE)

    FDA 510(k)
    FDA Class 2 ·Immunology

    ADVIA Centaur Total IgE (tIgE)

    FDA 510(k)
    FDA Class 2 ·Immunology

    ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE Calibrators/Total IgE Curve Controls, ImmunoCAP Specific IgE Calibrator Strip/Specific IgE Curve Control Strip, ImmunoCAP Specific IgE Calibrators/Specific IgE Curve Controls

    FDA 510(k)
    FDA Class 2 ·Immunology

    IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE CONTROLS, CONTROL LMH

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

    Other Clearances by Inova Diagnostics, Inc.

    K Number Device Name
    K243979 Aptiva APS IgA Reagent
    K223093 Aptiva APS IgG Reagent; Aptiva APS IgM Reagent
    K213403 Aptiva CTD Essential Reagent
    K200230 Aptiva Celiac Disease IgG Reagent
    K193604 Aptiva Celiac Disease IgA Reagent
    K192916 NOVA Lite DAPI dsDNA Crithidia luciliae Kit
    K190088 QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents
    K180971 QUANTA Flash Calprotectin and Fecal Extraction Device
    K180975 QUANTA Flash HMGCR Reagents
    K170993 QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Flash Calprotectin Extraction Buffer
    Search all 138 clearances from Inova Diagnostics, Inc. →