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FDA 510(k)

DIRECTIGEN NEISSENA MENNINGITIDIS GROUP B TEST

K-Number: K844407 · 1985-01-25

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic
Decision Date1985-01-25
Product CodeGTJ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

DIRECTIGEN NEISSENA MENNINGITIDIS GROUP B 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 1985-01-25 under 510(k) number K844407. The device is classified under product code GTJ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIRECTIGEN NEISSENA MENNINGITIDIS GROUP B TEST?

DIRECTIGEN NEISSENA MENNINGITIDIS GROUP B TEST is a medical device that received FDA 510(k) clearance on 1985-01-25. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K844407.

When did DIRECTIGEN NEISSENA MENNINGITIDIS GROUP B TEST receive FDA 510(k) clearance?

DIRECTIGEN NEISSENA MENNINGITIDIS GROUP B TEST received FDA 510(k) clearance on 1985-01-25, under 510(k) number K844407.

Who is the listed applicant for DIRECTIGEN NEISSENA MENNINGITIDIS GROUP B 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 NEISSENA MENNINGITIDIS GROUP B TEST?

The FDA product code for DIRECTIGEN NEISSENA MENNINGITIDIS GROUP B TEST is GTJ.

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Related Devices (Code: GTJ)

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.

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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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