Chromostreak

FDA 510(k) K000718 · Novamed , Ltd.

Substantially Equivalent

510(k) numberK000718

Submission

Device name
Chromostreak
Applicant
Novamed , Ltd.
Jerusalem, IL
Received
March 3, 2000
Decision date
August 24, 2000
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

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

510(k)DeviceApplicantDecision
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
K896296Inpouch-Tv PouchJSN · Traditional Biomed Diagnostics, Inc.01/29/1990SE
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

More from Dms Laboratories

510(k)DeviceDecision
K063477Novamed MRI Conditional Laryngoscope SetCCW · Traditional 02/09/2007SE
K062020Lifesound Esophageal StethoscopeBZT · Traditional 09/05/2006SE
K974428DipstreakJSI · Traditional 07/30/1998SE

Questions and answers

When was Chromostreak cleared by the FDA?

Chromostreak (K000718) received a 510(k) decision of Substantially Equivalent on August 24, 2000, 174 days after the submission was received.

What is the product code of K000718?

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