510(k) K092166

Device: S. AUREUS/CNS PNA FISH, MODEL KT005
Applicant: ADVANDX, INC.
510(k) number: K092166
Product code: NXX
Decision: Substantially Equivalent (SESE)
Decision date: 2009-11-23
Date received: 2009-07-21
Regulation: 866.3700
Classification name: Fish (fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Staphylococcus Aureus
Medical specialty: Microbiology
Review panel: Microbiology
Device class: 1
Clearance type: Traditional
Statement or summary: Statement
Third party reviewed: No

Applicant Contact#

Contact: PAULA E BULGER
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 NXX #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K113371	STAPHYLOCOCCUS QUICKFISH BC	Advandx, Inc.	2012-04-03
K091827	S. AUREUS PNA FISH	Advandx, Inc.	2009-08-18
K060099	S. AUREUS PNA FISH	Advandx, Inc.	2006-05-08

Legacy Summary#

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FDA Review#

Decision Summary