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FDA 510(k)

VZVSCAN(TM) LATEX AGGUTINATION TEST

K-Number: K912239 · 1991-06-11

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic
Decision Date1991-06-11
Product CodeGQW
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

VZVSCAN(TM) LATEX AGGUTINATION TEST 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 1991-06-11 under 510(k) number K912239. The device is classified under product code GQW. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VZVSCAN(TM) LATEX AGGUTINATION TEST?

VZVSCAN(TM) LATEX AGGUTINATION TEST is a medical device that received FDA 510(k) clearance on 1991-06-11. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K912239.

When did VZVSCAN(TM) LATEX AGGUTINATION TEST receive FDA 510(k) clearance?

VZVSCAN(TM) LATEX AGGUTINATION TEST received FDA 510(k) clearance on 1991-06-11, under 510(k) number K912239.

Who is the listed applicant for VZVSCAN(TM) LATEX AGGUTINATION TEST?

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 VZVSCAN(TM) LATEX AGGUTINATION TEST?

The FDA product code for VZVSCAN(TM) LATEX AGGUTINATION TEST is GQW.

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Related Devices (Code: GQW)

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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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