Cleared Special

SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM

K103340 · Harvest Technologies, Corp. · Hematology
Dec 2010
Decision
21d
Days
Class 1
Risk

About This 510(k) Submission

K103340 is an FDA 510(k) clearance for the SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION 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 December 6, 2010, 21 days after receiving the submission on November 15, 2010. This device falls under the Hematology review panel. Regulated under 21 CFR 862.2050.

Submission Details

510(k) Number K103340 FDA.gov
FDA Decision Cleared SESE
Date Received November 15, 2010
Decision Date December 06, 2010
Days to Decision 21 days
Submission Type Special
Review Panel Hematology (HE)
Summary Statement

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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