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

Related Records

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

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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