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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
510(k) Number K081345
Device Name AXP PLATFORM MARROW XPRESS SYSTEM MODEL 8-5137, 8-5138, 8-5139, 8-5140 (PRIMARY)
Applicant
Thermogenesis Corp.
2711 Citrus Rd.
Rancho Cordova,  CA  95742
Applicant Contact JOHN CHAPMAN, PHD
Correspondent
Thermogenesis Corp.
2711 Citrus Rd.
Rancho Cordova,  CA  95742
Correspondent Contact JOHN CHAPMAN, PHD
Regulation Number862.2050
Classification Product Code
JQC  
Date Received05/14/2008
Decision Date 07/10/2008
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Hematology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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