Cleared Traditional

GENESISCS COMPONENT CONCENTRATING SYSTEM

K070666 · Perfusion Partners & Assoc., Inc. · Hematology
Jun 2007
Decision
100d
Days
Class 1
Risk

About This 510(k) Submission

K070666 is an FDA 510(k) clearance for the GENESISCS COMPONENT CONCENTRATING SYSTEM, a Centrifuges (micro, Ultra, Refrigerated) For Clinical Use (Class I — General Controls, product code JQC), submitted by Perfusion Partners & Assoc., Inc. (Pahrump, US). The FDA issued a Cleared decision on June 20, 2007, 100 days after receiving the submission on March 12, 2007. This device falls under the Hematology review panel. Regulated under 21 CFR 862.2050.

Submission Details

510(k) Number K070666 FDA.gov
FDA Decision Cleared SESE
Date Received March 12, 2007
Decision Date June 20, 2007
Days to Decision 100 days
Submission Type Traditional
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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