AXP PLATFORM MARROW XPRESS SYSTEM MODEL 8-5137, 8-5138, 8-5139, 8-5140 - 8-5138

FDA 510(k)EUDAMED

Class I (US FDA 510(k))

510(k) K081345

Identifiers

510(k) Number: K081345 FDA 510(k)
FDA Product Code: JQC FDA 510(k)
Models / Variants: 8-5137 FDA 510(k)EUDAMED
8-5138 FDA 510(k)EUDAMED
8-5139 FDA 510(k)EUDAMED
8-5140 (primary) FDA 510(k)EUDAMED

Classification

Device Class: Class I FDA 510(k)
Legislation / Framework: 21 CFR Part 862.2050 FDA 510(k)
Regulation Number: 862.2050 FDA 510(k)
Advisory Committee: Clinical Chemistry FDA 510(k)
FDA Decision: SN FDA 510(k)

AXP PLATFORM MARROW XPRESS SYSTEM MODEL 8-5137, 8-5138, 8-5139, 8-5140 - 8-5138 by Thermogenesis Corp. — Class I — MDR, FDA_510K — listed in FDA 510(k)…

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class I	Active
FDA 510(k)	United States	FDA_510K	K081345	Class I	Active

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Manufacturer

Manufacturer: Thermogenesis Corp.

Sources (2)

FDA 510(k) K081345 24 fields · synced Jun 18, 2026
EUDAMED 1 fields · synced May 19, 2026