Inpouch-Tv Pouch

FDA 510(k) K896296 · Biomed Diagnostics, Inc.

Substantially Equivalent

510(k) numberK896296

Submission

Device name
Inpouch-Tv Pouch
Applicant
Biomed Diagnostics, Inc.
San Jose, CA, US
Received
October 31, 1989
Decision date
January 29, 1990
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JSN – Culture Media, Propagating Transport
Device class
Class I (low risk)
Regulation
21 CFR 866.2390
Specialty
Microbiology

Other 510(k)s with product code JSN

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K000718ChromostreakJSN · Traditional Novamed , Ltd.08/24/2000SE
K962745Enteric Pathogen Transport (Ept) (E1020,E1000)JSN · Traditional Prepared Media Laboratory, Inc.10/02/1996SE
K961756Cytoquant Viral Transport MediumJSN · Traditional Proteins Intl., Inc.05/17/1996SE
K961755Cytoquant Chlamydia Transport MediumJSN · Traditional Proteins Intl., Inc.05/17/1996SE
K881579Amies Transport Medium W/O CharcoalJSN · Traditional Acumedia Manufacturers, Inc.04/18/1988SE
K860967Virtran Viral Transporter (Modified)JSN · Traditional Diagnon Corp.04/04/1986SE
K841208Propagating TransportJSN · Traditional Smith River Biologicals04/05/1984SE
K83396810BJSN · Traditional Remel Co.12/30/1983SE
K834065A3BJSN · Traditional Remel Co.12/27/1983SE
K831186Rapid NFTJSN · Traditional Dms Laboratories05/09/1983SE

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Questions and answers

When was Inpouch-Tv Pouch cleared by the FDA?

Inpouch-Tv Pouch (K896296) received a 510(k) decision of Substantially Equivalent on January 29, 1990, 90 days after the submission was received.

What is the product code of K896296?

The FDA product code is JSN – Culture Media, Propagating Transport, a Class I (low risk) device regulated under 21 CFR 866.2390.