Pipette, Quantitative, Hematology

Device Code: 2292

Product Code(s): GJG

Device Classification Information

Device Type ID2292
Device NamePipette, Quantitative, Hematology
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 CodeGJG
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID2292
DevicePipette, Quantitative, Hematology
Product CodeGJG
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionManual Blood Cell Counting Device.
CFR Regulation Number864.6160 [🔎]
TPLC Last Update: 2019-04-02 20:09:01

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