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FDA 510(k)

MICROHEMATOCRIT ROTOR

K-Number: K930415 · 1993-03-23

ApplicantFisher Scientific Co., LLC
Decision Date1993-03-23
Product CodeGKG
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

MICROHEMATOCRIT ROTOR 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 1993-03-23 under 510(k) number K930415. The device is classified under product code GKG. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROHEMATOCRIT ROTOR?

MICROHEMATOCRIT ROTOR is a medical device that received FDA 510(k) clearance on 1993-03-23. The listed applicant is Fisher Scientific Co., LLC. The 510(k) number is K930415.

When did MICROHEMATOCRIT ROTOR receive FDA 510(k) clearance?

MICROHEMATOCRIT ROTOR received FDA 510(k) clearance on 1993-03-23, under 510(k) number K930415.

Who is the listed applicant for MICROHEMATOCRIT ROTOR?

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 MICROHEMATOCRIT ROTOR?

The FDA product code for MICROHEMATOCRIT ROTOR is GKG.

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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.

K915825MARATHON 6K GENERAL-PURPOSE CENTRIFUGEK915441MARATHON 13K/H MICROHEMATOCRIT 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: GKG)

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.

K961803SPUNCRIT (MODEL DRC-40)Micro Diagnostics Corp.K955795MULTI-CENTRIFUGENovonx, Inc.K925863SPUNCRITbioMerieux, Inc.K920207HERMLE Z230HLabnet Intl., Inc.K920759CRITSPIN MICRO-HEMATOCRITStat-Spin TechnologiesK913128HEMATASTAT C-70BSeparation Technology, Inc.

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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