Cleared Traditional

MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGE

K915441 · Fisher Scientific Co., LLC · Hematology
Jan 1992
Decision
35d
Days
Class 2
Risk

About This 510(k) Submission

K915441 is an FDA 510(k) clearance for the MARATHON 13K/H MICROHEMATOCRIT 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 January 8, 1992, 35 days after receiving the submission on December 4, 1991. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5600.

Submission Details

510(k) Number K915441 FDA.gov
FDA Decision Cleared SESE
Date Received December 04, 1991
Decision Date January 08, 1992
Days to Decision 35 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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