InTray GC

Q: When was InTray GC cleared by the FDA?

InTray GC (K210511) received a 510(k) decision of Substantially Equivalent on October 20, 2021, 239 days after the submission was received.

Q: What is the product code of K210511?

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) K210511 · Biomed Diagnostics Incorporated

Substantially Equivalent

510(k) numberK210511

Submission

Device name: InTray GC
Applicant: Biomed Diagnostics Incorporated
White City, OR, US
Received: February 23, 2021
Decision date: October 20, 2021
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

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

Other 510(k)s with product code JTY

510(k)	Device	Applicant	Decision
K993033	Intray GCJTY · Traditional	Biomed Diagnostics, Inc.	12/16/1999SE
K954986	GC Base W/ 1% GchiJTY · Traditional	Remel, L.P.	02/16/1996SE
K950196	Culture Media, for Isolation of Pathogenic NeisseriaJTY · Traditional	Bioclinical Systems, Inc.	06/30/1995SE
K933122	Microbiological Culture Media,Martin Lewis AgarJTY · Traditional	Bioclinical Systems, Inc.	02/09/1994SE
K933121	Microbiological Culture Media,Chocolate AgarJTY · Traditional	Bioclinical Systems, Inc.	02/03/1994SE
K934331	Thayer Martin, Modified Pill PocketJTY · Traditional	Hardy Diagnostics	12/21/1993SE
K934330	TransgrowJTY · Traditional	Hardy Diagnostics	12/17/1993SE
K931864	Martin Lewis with LinocmycinJTY · Traditional	Hardy Diagnostics	12/15/1993SE
K881552	Proteose No. 3 AgarJTY · Traditional	Acumedia Manufacturers, Inc.	04/18/1988SE
K881527	Casman Medium BaseJTY · Traditional	Acumedia Manufacturers, Inc.	04/18/1988SE

More from Acumedia Manufacturers, Inc.

510(k)	Device	Decision
K993033	Intray GCJTY · Traditional	12/16/1999SE
K896296	Inpouch-Tv PouchJSN · Traditional	01/29/1990SE

Questions and answers

When was InTray GC cleared by the FDA?

InTray GC (K210511) received a 510(k) decision of Substantially Equivalent on October 20, 2021, 239 days after the submission was received.

What is the product code of K210511?

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.