BEUDAMED
    Product Code: KKS FDA class 1 21 CFR 864.1850

    Acid, Periodic

    Hematology

    Periodic Acid is an oxidizing staining reagent used in hematology and histopathology laboratories as the key component of the Periodic Acid-Schiff (PAS) staining procedure, which detects and highlights polysaccharides, mucopolysaccharides, and glycoproteins in tissue sections. It is classified as FDA Class 1, indicating low risk subject to general controls only with no premarket submission required. The product code is KKS and the applicable regulation is 21 CFR 864.1850 in the Hematology specialty. This device is GMP exempt.

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    510(k)s
    0
    FEI Numbers
    8
    Registration Numbers
    8
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    KKS
    Device Class
    FDA class 1
    Regulation Number
    864.1850
    Medical Specialty
    Hematology
    Review Panel
    PA
    Submission Type
    4

    Device Characteristics

    ✓
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
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    Summary Malfunction Reporting

    FEI Numbers

    This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.