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

    RAICHEM AMYLASE REAGENT

    K Number: K861269 · Decision May 29, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30
    Same Product Code
    98
    Applicant Total
    63
    Review Days
    55

    Basic Information

    Device Name
    RAICHEM AMYLASE REAGENT
    K Number
    K861269
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1070
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    REAGENTS APPLICATIONS, INC.
    Date Received
    April 4, 1986
    Decision Date
    May 29, 1986
    Product Code
    JFJ
    Advisory Committee
    Clinical Chemistry
    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
    JFJ Catalytic Methods, Amylase

    Similar 510(k) Clearances

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

    Amylase2

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Atellica CH Amylase_2 (AMY_2)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINICAL SYSTEMS ELITROL I AND ELITROL II

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SYNCHRON SYSTEMS G7 AMYLASE (AMY7) REAGENT WITH MODEL(S) A71607

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry
    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
    K911899 RAICHEM SPIA C4 REAGENT
    K911900 RAICHEM SPIA C3 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. →