Directigen Meningitis Combo Test Kit

Q: What is the product code of K915330?

The FDA product code is GTJ – Antisera, All Groups, N. Meningitidis, a Class II (moderate risk) device regulated under 21 CFR 866.3390.

FDA 510(k) K915330 · Bd Becton Dickinson Vacutainer Systems Preanalytic

Substantially Equivalent

510(k) numberK915330

Submission

Device name: Directigen Meningitis Combo Test Kit
Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
Franklin Lakes, NJ, US
Received: November 26, 1991
Decision date: March 23, 1992
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: GTJ – Antisera, All Groups, N. Meningitidis
Device class: Class II (moderate risk)
Regulation: 21 CFR 866.3390
Specialty: Microbiology

Other 510(k)s with product code GTJ

510(k)	Device	Applicant	Decision
K952791	Directigen Meningitis Combo TestGTJ · Traditional	Bd Becton Dickinson Vacutainer Systems Preanalytic	05/30/1996SE
K910210	Slidex Meningite-Kit 5GTJ · Traditional	Vitek Systems, Inc.	08/12/1991SE
K885004	Bactigen(R) N. MeningitidisGTJ · Traditional	Armkel, LLC	02/07/1989SE
K870089	Immunoscan(Tm) Direct Neisseria Meningitidis KitGTJ · Traditional	Microscan Div. Baxter Healthcare Corp.	03/17/1987SE
K854852	Wellcogen Bacterial Antigen KitGTJ · Traditional	Wellcome Diagnostics	02/04/1986SE
K854851	Wellcogen N. Meningitidis B/E. Coli K1 ZL24GTJ · Traditional	Wellcome Diagnostics	02/04/1986SE
K844999	Phadebact CSF TestGTJ · Traditional	Pharmacia, Inc.	10/17/1985SE
K851691	Willcogen Meningitidis Kit ZL25GTJ · Traditional	Wellcome Diagnostics	06/10/1985SE
K844762	Meningococcus Group B Monoclonal Antibody ZM-51GTJ · Traditional	Wellcome Diagnostics	06/04/1985SE
K844407	Directigen Neissena Menningitidis Group B TestGTJ · Traditional	Bd Becton Dickinson Vacutainer Systems Preanalytic	01/25/1985SE

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K000762	Moxifloxacin, 5 Ug, BBL Sensi-DiscJTN · Traditional	04/25/2000SE
K000829	Gatifloxacin, 5 Ug, BBL Sensi-DiscJTN · Traditional	04/13/2000SE
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K992734	Becton Dickinson SyringeMEG · Traditional	10/01/1999SE
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Questions and answers

When was Directigen Meningitis Combo Test Kit cleared by the FDA?

Directigen Meningitis Combo Test Kit (K915330) received a 510(k) decision of Substantially Equivalent on March 23, 1992, 118 days after the submission was received.

What is the product code of K915330?

The FDA product code is GTJ – Antisera, All Groups, N. Meningitidis, a Class II (moderate risk) device regulated under 21 CFR 866.3390.