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FDA 510(k)

QBC ACCUTUBE

K-Number: K953340 · 1995-10-05

ApplicantBecton Dickinson Diagnostic Instrument Systems
Decision Date1995-10-05
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

QBC ACCUTUBE is the device name listed in this FDA 510(k) record. The listed applicant is Becton Dickinson Diagnostic Instrument Systems. It received FDA 510(k) clearance on 1995-10-05 under 510(k) number K953340. The device is classified under product code GKZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QBC ACCUTUBE?

QBC ACCUTUBE is a medical device that received FDA 510(k) clearance on 1995-10-05. The listed applicant is Becton Dickinson Diagnostic Instrument Systems. The 510(k) number is K953340.

When did QBC ACCUTUBE receive FDA 510(k) clearance?

QBC ACCUTUBE received FDA 510(k) clearance on 1995-10-05, under 510(k) number K953340.

Who is the listed applicant for QBC ACCUTUBE?

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

What is the FDA product code for QBC ACCUTUBE?

The FDA product code for QBC ACCUTUBE is GKZ.

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Other records listing Becton Dickinson Diagnostic Instrument Systems 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.

K954923BACTEC FUNGAL MEDIUMK954932BBL MGIT PRODUCTSK962210BACTEC 9050 SYSTEMK946268BACTEC(R) 9000TB SYSTEMK960827QBC ACCUTUBE(423406)/QBC AUTOREAD(424571)K954921BACTEC STANDARD/10 AEROBIC/F CULTURE VIALS

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Related Devices (Code: GKZ)

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.

K260781Yumizen H550HORIBA ABX SASK253212XR-Series (XR-10, XR-20) Automated Hematology AnalyzersSysmex America, Inc.K243348Athelas HomeAthelas, Inc.K251249Tru Hematology TestTruvian Sciences, Inc.K250943Sysmex XR-Series (XR-10) Automated Hematology AnalyzerSysmex America, Inc.K251371Sysmex XR-Series (XR-20) Automated Hematology AnalyzerSysmex America, 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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