Culture Medium for Pathogenic Neisseria Ssp.Mi

Q: What is the product code of K850732?

The FDA product code is JTY – Culture Media, For Isolation Of Pathogenic Neisseria, a Class II (moderate risk) device regulated under 21 CFR 866.2410.

FDA 510(k) K850732 · Roseville Medical Laboratoriesu

Substantially Equivalent

510(k) numberK850732

Submission

Device name: Culture Medium for Pathogenic Neisseria Ssp.Mi
Applicant: Roseville Medical Laboratoriesu
Roseville, CA, US
Received: February 20, 1985
Decision date: March 20, 1985
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code: JTY – Culture Media, For Isolation Of Pathogenic Neisseria
Device class: Class II (moderate risk)
Regulation: 21 CFR 866.2410
Specialty: Microbiology

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K933122	Microbiological Culture Media,Martin Lewis AgarJTY · Traditional	Bioclinical Systems, Inc.	02/09/1994SE
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K934331	Thayer Martin, Modified Pill PocketJTY · Traditional	Hardy Diagnostics	12/21/1993SE
K934330	TransgrowJTY · Traditional	Hardy Diagnostics	12/17/1993SE
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K881552	Proteose No. 3 AgarJTY · Traditional	Acumedia Manufacturers, Inc.	04/18/1988SE

More from Acumedia Manufacturers, Inc.

510(k)	Device	Decision
K850738	Supplement for Culture MediumJSK · Traditional	03/20/1985SE
K850737	Transport Culture MediumPPM · Traditional	03/20/1985SE
K850736	Selective Culture MediumJSI · Traditional	03/20/1985SE
K850734	Differential Culture MediumJSE · Traditional	03/20/1985SE
K850733	Multipurpose Culture MediumJSG · Traditional	03/20/1985SE
K850731	Culture Medium for Antimicrobial Suscep. TestingJTZ · Traditional	03/20/1985SE
K850735	Enriched Culture MediumKZI · Traditional	03/16/1985SE

Questions and answers

When was Culture Medium for Pathogenic Neisseria Ssp.Mi cleared by the FDA?

Culture Medium for Pathogenic Neisseria Ssp.Mi (K850732) received a 510(k) decision of Substantially Equivalent on March 20, 1985, 28 days after the submission was received.

What is the product code of K850732?

The FDA product code is JTY – Culture Media, For Isolation Of Pathogenic Neisseria, a Class II (moderate risk) device regulated under 21 CFR 866.2410.