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FDA 510(k)

QBC CENTRIFUGAL HEMATOLOGY SYSTEM

K-Number: K821803 · 1982-09-14

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic
Decision Date1982-09-14
Product CodeGKG
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

QBC CENTRIFUGAL HEMATOLOGY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. It received FDA 510(k) clearance on 1982-09-14 under 510(k) number K821803. 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 QBC CENTRIFUGAL HEMATOLOGY SYSTEM?

QBC CENTRIFUGAL HEMATOLOGY SYSTEM is a medical device that received FDA 510(k) clearance on 1982-09-14. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K821803.

When did QBC CENTRIFUGAL HEMATOLOGY SYSTEM receive FDA 510(k) clearance?

QBC CENTRIFUGAL HEMATOLOGY SYSTEM received FDA 510(k) clearance on 1982-09-14, under 510(k) number K821803.

Who is the listed applicant for QBC CENTRIFUGAL HEMATOLOGY SYSTEM?

The FDA 510(k) record lists Bd Becton Dickinson Vacutainer Systems Preanalytic as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QBC CENTRIFUGAL HEMATOLOGY SYSTEM?

The FDA product code for QBC CENTRIFUGAL HEMATOLOGY SYSTEM is GKG.

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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.K930415MICROHEMATOCRIT ROTORFisher Scientific Co., LLCK925863SPUNCRITbioMerieux, Inc.K920207HERMLE Z230HLabnet Intl., Inc.K920759CRITSPIN MICRO-HEMATOCRITStat-Spin 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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