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FDA 510(k)

DIRECTIGEN NEISSERIA MENINGITIDIS TEST

K-Number: K920274 · 1992-03-18

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic
Decision Date1992-03-18
Product CodeGTI
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

DIRECTIGEN NEISSERIA MENINGITIDIS 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 1992-03-18 under 510(k) number K920274. The device is classified under product code GTI. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIRECTIGEN NEISSERIA MENINGITIDIS TEST?

DIRECTIGEN NEISSERIA MENINGITIDIS TEST is a medical device that received FDA 510(k) clearance on 1992-03-18. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K920274.

When did DIRECTIGEN NEISSERIA MENINGITIDIS TEST receive FDA 510(k) clearance?

DIRECTIGEN NEISSERIA MENINGITIDIS TEST received FDA 510(k) clearance on 1992-03-18, under 510(k) number K920274.

Who is the listed applicant for DIRECTIGEN NEISSERIA MENINGITIDIS 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 DIRECTIGEN NEISSERIA MENINGITIDIS TEST?

The FDA product code for DIRECTIGEN NEISSERIA MENINGITIDIS TEST is GTI.

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Other records listing Bd Becton Dickinson Vacutainer Systems Preanalytic as applicant

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Related Devices (Code: GTI)

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.

K841308DIRECTIGEN MENNINGITIS TEST KITBd Becton Dickinson Vacutainer Systems Preanalytic

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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