510(k) K083074

Device: AVANDX E. FAECALIS/OE PNA FISH CULTURE IDENTIFICATION KIT
Applicant: ADVANDX, INC.
510(k) number: K083074
Product code: OAH
Decision: Substantially Equivalent (SESE)
Decision date: 2009-07-24
Date received: 2008-10-15
Regulation: 866.3740
Classification name: Fish (fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis
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 OAH #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K121991	ENTEROCOCCUS QUICKFISH BC	Advandx, Inc.	2013-01-07
K082612	GBS PNA FISH	Advandx, Inc.	2009-05-05
K063127	ENTEROCOCCUS FAECALIS PNA FISH	Advandx, Inc.	2006-12-22

Legacy Summary#

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FDA Review#

Decision Summary