510(k) K092784

Device: C. ALBICANS/C. GLABRATA PNA FISH
Applicant: ADVANDX, INC.
510(k) number: K092784
Product code: NZS
Decision: Substantially Equivalent (SESE)
Decision date: 2010-03-12
Date received: 2009-09-10
Regulation: 866.2660
Classification name: Fish (fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Yeast
Medical specialty: Microbiology
Review panel: Microbiology
Device class: 1
Clearance type: Traditional
Statement or summary: Statement
Third party reviewed: No

Applicant Contact#

Contact: HENRIK STENDER
Address: 10a Roessler Rd. Woburn MA US 01801 01801

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code NZS #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K093024	YEAST TRAFFIC LIGHT PNA FISH	Advandx, Inc.	2010-07-15
K092655	C. ALBICANS PNA FISH	Advandx, Inc.	2010-01-19

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Decision Summary