BEUDAMED
    Product Code: GHR FDA class 2 21 CFR 864.5700

    Reagent, Platelet Aggregation

    Hematology

    Reagent, Platelet Aggregation (product code GHR) is a hematology reagent used to induce and measure platelet aggregation in vitro, providing information about platelet function and aiding in the diagnosis of platelet disorders and monitoring of antiplatelet therapy. This device is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. Regulated under 21 CFR 864.5700 in the Hematology specialty (HE), it is eligible for third-party review.

    View on FDA
    510(k)s
    11
    FEI Numbers
    4
    Registration Numbers
    4
    Unique Applicants
    3
    Years Active
    31

    Basic Information

    Product Code
    GHR
    Device Class
    FDA class 2
    Regulation Number
    864.5700
    Medical Specialty
    Hematology
    Review Panel
    HE
    Submission Type
    1

    Device Characteristics

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

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 11 510(k) clearances via K numbers.

    K Number Device Name
    K061991 PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA
    K952252 ADP REAGENT, MODIFIED
    K922800 PLATELET AGGREGATION REAGENTS
    K910800 ADP REAGENT
    K910706 COLLAGEN REAGENT CAT. NO. 5368
    K910680 EPINEPHRINE REAGENT, CAT. NO. 5367
    K910286 PLATELET AGGREGATION REAGENTS
    K900792 RISTOCETIN
    K832428 PLATELET AGGREGATION REAGENT SET
    K820422 PLATELET AGGREGOMETERS
    K760198 KIT, PLATELET AGGREGATION REAGENT (#390)

    FEI Numbers

    This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.