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FDA 510(k)

QBC MALARIA SYSTEM

K-Number: K891276 · 1989-08-03

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic
Decision Date1989-08-03
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

QBC MALARIA 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 1989-08-03 under 510(k) number K891276. 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 MALARIA SYSTEM?

QBC MALARIA SYSTEM is a medical device that received FDA 510(k) clearance on 1989-08-03. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K891276.

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

QBC MALARIA SYSTEM received FDA 510(k) clearance on 1989-08-03, under 510(k) number K891276.

Who is the listed applicant for QBC MALARIA 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 MALARIA SYSTEM?

The FDA product code for QBC MALARIA SYSTEM 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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