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

    RAICHEM(TM) SPIA(TM) IGG REAGENTS

    K Number: K894416 · Decision Aug 1, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    1
    Applicant Total
    63
    Review Days
    15

    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
    RAICHEM(TM) SPIA(TM) IGG REAGENTS
    K Number
    K894416
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.5530
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Reagents Applications, Inc.
    Date Received
    July 17, 1989
    Decision Date
    August 1, 1989
    Product Code
    KTO
    Advisory Committee
    Immunology
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KTO Reagent, Immunoassay, Igg

    Similar 510(k) Clearances

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

    KALLESTAD QUANTIMETRIC PLUS IGG REAGENT KIT

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

    Other Clearances by Reagents Applications, Inc.

    K Number Device Name
    K982056 RAICHEM CO2 REAGENT
    K972853 CHOLESTEROL RAPID LIQUID REAGENT
    K922904 RAI-TROL FRUCTOSAMINE SERUM CONTROLS I AND II
    K915191 RAI-TROL ELEVATED LIPIDS CONTROL
    K913398 RAICHEM(TM) CREATINE KINASE-MB REAGENT
    K911900 RAICHEM SPIA C3 REAGENT
    K911899 RAICHEM SPIA C4 REAGENT
    K911898 RAICHEM(TM) SPIA(TM) HAPTOGLOBIN REAGENT
    K905084 RAICHEM CREATINE KINASE REAGENT, OPTIMIZED UV
    K905085 RAICHEM GGT REAGENT
    Search all 63 clearances from Reagents Applications, Inc. →