510(k) K092655

Device: C. ALBICANS PNA FISH
Applicant: ADVANDX, INC.
510(k) number: K092655
Product code: NZS
Decision: Substantially Equivalent (SESE)
Decision date: 2010-01-19
Date received: 2009-08-28
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: 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 NZS #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K093024	YEAST TRAFFIC LIGHT PNA FISH	Advandx, Inc.	2010-07-15
K092784	C. ALBICANS/C. GLABRATA PNA FISH	Advandx, Inc.	2010-03-12

Legacy Summary#

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FDA Review#

Decision Summary