Cleared Traditional

MARATHON 6K GENERAL-PURPOSE CENTRIFUGE

K915825 · Fisher Scientific Co., LLC · Hematology
Mar 1992
Decision
72d
Days
Class 2
Risk

About This 510(k) Submission

K915825 is an FDA 510(k) clearance for the MARATHON 6K GENERAL-PURPOSE CENTRIFUGE, a Instrument, Hematocrit, Automated (Class II — Special Controls, product code GKF), submitted by Fisher Scientific Co., LLC (Indiana, US). The FDA issued a Cleared decision on March 11, 1992, 72 days after receiving the submission on December 30, 1991. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5600.

Submission Details

510(k) Number K915825 FDA.gov
FDA Decision Cleared SESE
Date Received December 30, 1991
Decision Date March 11, 1992
Days to Decision 72 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GKF — Instrument, Hematocrit, Automated
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5600

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