Centrifuge, Microsedimentation

Device Code: 2271

Product Code(s): GHK

Device Classification Information

Device Type ID2271
Device NameCentrifuge, Microsedimentation
Regulation DescriptionMicrosedimentation Centrifuge.
Regulation Medical SpecialtyHematology
Review PanelHematology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(K) Exempt
CFR Regulation Number864.5350 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeGHK
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID2271
DeviceCentrifuge, Microsedimentation
Product CodeGHK
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionMicrosedimentation Centrifuge.
CFR Regulation Number864.5350 [🔎]
TPLC Last Update: 2019-04-02 20:08:43

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