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FDA 510(k)

QEA SODIUM/POTASSIUM ANALYZER

K-Number: K832036 · 1983-07-18

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic
Decision Date1983-07-18
Product CodeCEM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

QEA SODIUM/POTASSIUM ANALYZER 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 1983-07-18 under 510(k) number K832036. The device is classified under product code CEM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QEA SODIUM/POTASSIUM ANALYZER?

QEA SODIUM/POTASSIUM ANALYZER is a medical device that received FDA 510(k) clearance on 1983-07-18. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K832036.

When did QEA SODIUM/POTASSIUM ANALYZER receive FDA 510(k) clearance?

QEA SODIUM/POTASSIUM ANALYZER received FDA 510(k) clearance on 1983-07-18, under 510(k) number K832036.

Who is the listed applicant for QEA SODIUM/POTASSIUM ANALYZER?

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 QEA SODIUM/POTASSIUM ANALYZER?

The FDA product code for QEA SODIUM/POTASSIUM ANALYZER is CEM.

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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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