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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Devices

BrandModelCompanyProduct codesPrimary DI
CRYOcheck™ Lupus Positive ControlCCLP-05Precision Biologic IncGGC GGN00843876000145
CRYOcheck™ Lupus Positive ControlCCLP-10Precision Biologic IncGGC GGN00843876000152