Pipette, Diluting

Device Code: 2265

Product Code(s): GGY

Device Classification Information

Device Type ID2265
Device NamePipette, Diluting
Regulation DescriptionManual Blood Cell Counting Device.
Regulation Medical SpecialtyHematology
Review PanelHematology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(K) Exempt
CFR Regulation Number864.6160 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeGGY
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID2265
DevicePipette, Diluting
Product CodeGGY
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionManual Blood Cell Counting Device.
CFR Regulation Number864.6160 [🔎]
TPLC Last Update: 2019-04-02 20:08:38

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