510(k) K121991

Device: ENTEROCOCCUS QUICKFISH BC
Applicant: ADVANDX, INC.
510(k) number: K121991
Product code: OAH
Decision: Substantially Equivalent (SESE)
Decision date: 2013-01-07
Date received: 2012-07-06
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: BENJAMIN S CRYSTAL
Address: 400 Tradecenter Suite 6990 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
K083074	AVANDX E. FAECALIS/OE PNA FISH CULTURE IDENTIFICATION KIT	Advandx, Inc.	2009-07-24
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