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510(k) K222613

Device
ARX Liquid Amies Collection & Transport System
Applicant
Arx Sciences, Inc.
510(k) number
K222613
Product code
LIO
Decision
Substantially Equivalent (SESE)
Decision date
2024-03-27
Date received
2022-08-30
Regulation
866.2900
Classification name
Device, Specimen Collection
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Chad Werts
Address
160 Lawrence Bell Dr. Suite 120 Amherst NY US 14221 14221

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LIO#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K131630PURITAN AMIES MEDIUM COLLECTION AND TRANSPORT SYSTEMPuritan Medical Products, LLC2013-10-21
K120846TRANSPORT CULTURE MEDIUM DEVICEPuritan Medical Products, LLC2012-06-08
K103805MEDICAL WIRE & EQUIPMENT S-TRANSWAB (OR SIGMA-TRANSWAB) LIQUID AMIES COLLECTION AND TRANSPORT DEVICEMedical Wire & Equipment Company (Bath), Ltd.2011-01-25
K082472VIROCULT, MODEL MW950Medical Wire & Equipment Company (Bath), Ltd.2008-12-30
K070062COPROSET SALMONELLA AND SHIGELLA, URISET PRESERVATIVE TUBES AND SWAB SET GENERAL USEDiesse Diagnostica Senese S.P.A.2007-07-30
K013711BACTI-SWAB DRYRemel Co.2001-11-26
K003761NAT - NUCLEIC ACID TRANSPORTMedical Packaging Corp.2001-05-31
K983119ENTERO-TEST HP, MODEL #102-01Hdc Corp.1999-03-15
K981391PAR-ONERemel, Inc.1998-07-14
K964144PARACON PLUS FORMALIN - PCP-F, PARACON PLUS SAF - PCP-SAF AND PARACON PLUS MF - PCP-MFPara Scientific Co.1996-11-27
K963986STP SYSTEM PVA WITH ZINCSage Products, Inc.1996-11-08
K964026STP SYSTEM - SAFSage Products, Inc.1996-11-07
K964027STP SYSTEM-PVA WITH MERCURYSage Products, Inc.1996-11-01
K960997STARSWAB CULTURE COLLECTION AND TRANSPORT SYSTEMStarplex Scientific, Inc.1996-04-03
K953929MID-STREAM COLLECTION SET-STERILETrinity Laboratories, Inc.1995-11-16