Cleared Abbreviated

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

K081345 · Thermogenesis Corp. · Hematology
Jul 2008
Decision
57d
Days
Class 1
Risk

About This 510(k) Submission

K081345 is an FDA 510(k) clearance for the AXP PLATFORM MARROW XPRESS SYSTEM MODEL 8-5137, 8-5138, 8-5139, 8-5140 (PRIMARY), a Centrifuges (micro, Ultra, Refrigerated) For Clinical Use (Class I — General Controls, product code JQC), submitted by Thermogenesis Corp. (Rancho Cordova, US). The FDA issued a Cleared decision on July 10, 2008, 57 days after receiving the submission on May 14, 2008. This device falls under the Hematology review panel. Regulated under 21 CFR 862.2050.

Submission Details

510(k) Number K081345 FDA.gov
FDA Decision Cleared SN
Date Received May 14, 2008
Decision Date July 10, 2008
Days to Decision 57 days
Submission Type Abbreviated
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code JQC — Centrifuges (micro, Ultra, Refrigerated) For Clinical Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2050

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