Control, Platelet

Device Code: 2297

Product Code(s): GJP

Device Classification Information

Device Type ID2297
Device NameControl, Platelet
Regulation DescriptionHematology Quality Control Mixture.
Regulation Medical SpecialtyHematology
Review PanelHematology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(K) Exempt
CFR Regulation Number864.8625 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeGJP
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Program

Recognized Standards

Total Product Life Cycle

Device Type ID2297
DeviceControl, Platelet
Product CodeGJP
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionHematology Quality Control Mixture.
CFR Regulation Number864.8625 [🔎]
TPLC Last Update: 2019-04-02 20:09:07

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