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FDA 510(k)

DIRECTIGEN NEISSERIA MENINGITIDIS

K-Number: K830646 · 1983-05-27

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic
Decision Date1983-05-27
Product Code
DecisionSubstantially Equivalent

Device Summary

DIRECTIGEN NEISSERIA MENINGITIDIS 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 1983-05-27 under 510(k) number K830646. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIRECTIGEN NEISSERIA MENINGITIDIS?

DIRECTIGEN NEISSERIA MENINGITIDIS is a medical device that received FDA 510(k) clearance on 1983-05-27. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K830646.

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

DIRECTIGEN NEISSERIA MENINGITIDIS received FDA 510(k) clearance on 1983-05-27, under 510(k) number K830646.

Who is the listed applicant for DIRECTIGEN NEISSERIA MENINGITIDIS?

The FDA 510(k) record lists Bd Becton Dickinson Vacutainer Systems Preanalytic as the applicant. This does not by itself establish the device manufacturer.

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Other records listing Bd Becton Dickinson Vacutainer Systems Preanalytic as applicant

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.

K003062BACTEC MGIT 960 SIR KITSK0035530.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGEK003461BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLEK002938B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/16K001364BD DIRECTIGEN FLU A+BK000762MOXIFLOXACIN, 5 UG, BBL SENSI-DISC

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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