Pipette, Sahli

Device Code: 2264

Product Code(s): GGX

Device Classification Information

Device Type ID2264
Device NamePipette, Sahli
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 CodeGGX
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID2264
DevicePipette, Sahli
Product CodeGGX
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionManual Blood Cell Counting Device.
CFR Regulation Number864.6160 [🔎]
TPLC Last Update: 2019-04-02 20:08:37

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