Cleared Traditional

SMARTPREP2 CENTRIFUGE SYSTEM

K052925 · Harvest Technologies, Corp. · Hematology
Jan 2006
Decision
78d
Days
Class 1
Risk

About This 510(k) Submission

K052925 is an FDA 510(k) clearance for the SMARTPREP2 CENTRIFUGE SYSTEM, a Centrifuges (micro, Ultra, Refrigerated) For Clinical Use (Class I — General Controls, product code JQC), submitted by Harvest Technologies, Corp. (Plymouth, US). The FDA issued a Cleared decision on January 4, 2006, 78 days after receiving the submission on October 18, 2005. This device falls under the Hematology review panel. Regulated under 21 CFR 862.2050.

Submission Details

510(k) Number K052925 FDA.gov
FDA Decision Cleared SESE
Date Received October 18, 2005
Decision Date January 04, 2006
Days to Decision 78 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

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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