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FDA 510(k)

DIRECTIGEN MENINGITIS COMBO TEST

K-Number: K952791 · 1996-05-30

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic
Decision Date1996-05-30
Product CodeGTJ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

DIRECTIGEN MENINGITIS COMBO 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 1996-05-30 under 510(k) number K952791. 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 MENINGITIS COMBO TEST?

DIRECTIGEN MENINGITIS COMBO TEST is a medical device that received FDA 510(k) clearance on 1996-05-30. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K952791.

When did DIRECTIGEN MENINGITIS COMBO TEST receive FDA 510(k) clearance?

DIRECTIGEN MENINGITIS COMBO TEST received FDA 510(k) clearance on 1996-05-30, under 510(k) number K952791.

Who is the listed applicant for DIRECTIGEN MENINGITIS COMBO 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 MENINGITIS COMBO TEST?

The FDA product code for DIRECTIGEN MENINGITIS COMBO 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.

K915330DIRECTIGEN MENINGITIS COMBO TEST KITBd Becton Dickinson Vacutainer Systems PreanalyticK910210SLIDEX MENINGITE-KIT 5Vitek Systems, Inc.K885004BACTIGEN(R) N. MENINGITIDISArmkel, LLCK870089IMMUNOSCAN(TM) DIRECT NEISSERIA MENINGITIDIS KITMicroscan Div. Baxter Healthcare Corp.K854851WELLCOGEN N. MENINGITIDIS B/E. COLI K1 ZL24Wellcome DiagnosticsK854852WELLCOGEN BACTERIAL ANTIGEN KITWellcome Diagnostics

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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