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

    AMY REAGENT

    K Number: K852001 · Decision Jun 10, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    98
    Applicant Total
    33
    Review Days
    34

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    Basic Information

    Device Name
    AMY REAGENT
    K Number
    K852001
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1070
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Alpkem Corp.
    Date Received
    May 7, 1985
    Decision Date
    June 10, 1985
    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

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    Other Clearances by Alpkem Corp.

    K Number Device Name
    K894011 TOTAL GALACTOSE
    K891070 PHENYLALANINE (NINHYDRIN REACTION)
    K890334 TOTAL CHOLESTEROL REAGENT
    K890337 TRIGLYCERIDES - GPO REAGENT
    K890336 GLUCOSE (GOD) REAGENT
    K890332 RFA/2 RAPID FLOW ANALYZER W/COMPUTER
    K890335 SODIUM HYDROXIDE SOLUTION, CREATININE REAG./DILU.
    K890333 ALBUMIN REAGENT
    K883020 RFA-300 RAPID FLOW ANALYZER W/COMPUTER
    K860367 MAGNESIUM (SUBSTRATE, ENZYME, REAGENT)
    Search all 33 clearances from Alpkem Corp. →