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FDA 510(k)

QBC ACCUTUBE(423406)/QBC AUTOREAD(424571)

K-Number: K960827 · 1996-05-17

ApplicantBecton Dickinson Diagnostic Instrument Systems
Decision Date1996-05-17
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

QBC ACCUTUBE(423406)/QBC AUTOREAD(424571) 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 1996-05-17 under 510(k) number K960827. 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(423406)/QBC AUTOREAD(424571)?

QBC ACCUTUBE(423406)/QBC AUTOREAD(424571) is a medical device that received FDA 510(k) clearance on 1996-05-17. The listed applicant is Becton Dickinson Diagnostic Instrument Systems. The 510(k) number is K960827.

When did QBC ACCUTUBE(423406)/QBC AUTOREAD(424571) receive FDA 510(k) clearance?

QBC ACCUTUBE(423406)/QBC AUTOREAD(424571) received FDA 510(k) clearance on 1996-05-17, under 510(k) number K960827.

Who is the listed applicant for QBC ACCUTUBE(423406)/QBC AUTOREAD(424571)?

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(423406)/QBC AUTOREAD(424571)?

The FDA product code for QBC ACCUTUBE(423406)/QBC AUTOREAD(424571) is GKZ.

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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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