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

    PAPINCOLABU STAIN EA-36/50/65 & OG-6

    K Number: K823329 · Decision Dec 28, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    0
    Applicant Total
    20
    Review Days
    50

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    Basic Information

    Device Name
    PAPINCOLABU STAIN EA-36/50/65 & OG-6
    K Number
    K823329
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.1850
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Accra Laboratories, Inc.
    Date Received
    November 8, 1982
    Decision Date
    December 28, 1982
    Product Code
    HZL
    Advisory Committee
    Hematology
    Review Advisory Committee
    PA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HZL Phloxine B

    Other Clearances by Accra Laboratories, Inc.

    K Number Device Name
    K851493 KINYOUN ACID FAST STAIN KIT
    K851494 TWO-STEP ACID FAST BACTERIA STAIN
    K843427 GILL PAPANICOLAOU STAIN EA-1 & 2 OG-6
    K843425 HARRIS HEMATOXYLIN, MERCURY FREE, ACID
    K843428 BIOFIX
    K843426 EOSIN Y 1% ALCOHOLIC
    K843429 GRAM STAIN SET W/STABILIZED IODINE
    K831090 HEMATOXYLIN GILL FORMULATION IX#56016
    K830542 HEMAQUIK II STAINING SOLUTION #55961
    K823328 HARRIS HEMATOXYLIN
    Search all 20 clearances from Accra Laboratories, Inc. →