Chamber, Environmental For The Storage Of Platelet Concentrate

Device Code: 2393

Product Code(s): KSH

Device Classification Information

Device Type ID2393
Device NameChamber, Environmental For The Storage Of Platelet Concentrate
Regulation DescriptionEnvironmental Chamber For Storage Of Platelet Concentrate.
Regulation Medical SpecialtyHematology
Review PanelHematology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(K) Exempt
CFR Regulation Number864.9575 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeKSH
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID2393
DeviceChamber, Environmental For The Storage Of Platelet Concentrate
Product CodeKSH
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionEnvironmental Chamber For Storage Of Platelet Concentrate.
CFR Regulation Number864.9575 [🔎]
TPLC Last Update: 2019-04-02 20:11:04

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