Part 864 Subpart K—Products Used In Establishments That Manufacture HCT/Ps

FDA submissions for Part 864 Subpart K—Products Used In Establishments That Manufacture HCT/Ps in the Hematology (HE) review panel, including product codes and regulations.

Section range: § 864.9900

CFR Part: 864

Product Codes

Product CodeDevice NameRegulationClassDevices
OAOCord Blood Processing System And Storage Container864.990020
OOFCryogenic Cord Blood Storage Container864.990020
Innolitics

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