Cleared Traditional

MARROWSTIM CONCENTRATION KIT AND MARROWSTIM MINI CONCENTRATION KIT

K071934 · Biomet Manufacturing Corp · Hematology
Oct 2007
Decision
90d
Days
Class 1
Risk

About This 510(k) Submission

K071934 is an FDA 510(k) clearance for the MARROWSTIM CONCENTRATION KIT AND MARROWSTIM MINI CONCENTRATION KIT, a Centrifuges (micro, Ultra, Refrigerated) For Clinical Use (Class I — General Controls, product code JQC), submitted by Biomet Manufacturing Corp (Warsaw, US). The FDA issued a Cleared decision on October 11, 2007, 90 days after receiving the submission on July 13, 2007. This device falls under the Hematology review panel. Regulated under 21 CFR 862.2050.

Submission Details

510(k) Number K071934 FDA.gov
FDA Decision Cleared SESE
Date Received July 13, 2007
Decision Date October 11, 2007
Days to Decision 90 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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