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FDA 510(k)

MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGE

K-Number: K915441 · 1992-01-08

ApplicantFisher Scientific Co., LLC
Decision Date1992-01-08
Product CodeGKF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGE is the device name listed in this FDA 510(k) record. The listed applicant is Fisher Scientific Co., LLC. It received FDA 510(k) clearance on 1992-01-08 under 510(k) number K915441. The device is classified under product code GKF. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGE?

MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGE is a medical device that received FDA 510(k) clearance on 1992-01-08. The listed applicant is Fisher Scientific Co., LLC. The 510(k) number is K915441.

When did MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGE receive FDA 510(k) clearance?

MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGE received FDA 510(k) clearance on 1992-01-08, under 510(k) number K915441.

Who is the listed applicant for MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGE?

The FDA 510(k) record lists Fisher Scientific Co., LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGE?

The FDA product code for MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGE is GKF.

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Other records listing Fisher Scientific Co., LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K930415MICROHEMATOCRIT ROTORK915825MARATHON 6K GENERAL-PURPOSE CENTRIFUGEK890534MODIFIED URIQUAL(TM) URINALYSIS CONTROL LEVEL 1K881275URIQUAL(TM) URINALYSIS CONTROLS (HUMAN) I & IIK874054FISHER DIAGNOSTICS HEMATALL III LAS REAGENTK872916HISTOMATIC SLIDE STAINER, CODE-ON VERSION

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Related Devices (Code: GKF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K160415GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation)Instrumentation Laboratory COK983551CRIT-SCAN II MONITORIn-Line Diagnostics Corp.K981426STAT PROFILE ULTRA F,G,H,I,J,K, AND L ANALYZERSNova Biomedical Corp.K981425STAT PROFILE ULTRA A, B, C, D, AND E ANALYZERSNova Biomedical Corp.K981427STAT PROFILE M ANALYZERNova Biomedical Corp.K953519MICROSPIN 24Vulcon Technologies

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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