FDA 510(k) Applications for Medical Device Product Code "LIO"
(Device, Specimen Collection)

FDA 510(k) Number Applicant Device Name Decision Date
K222613 ARX Sciences, Inc. ARX Liquid Amies Collection & Transport System 03/27/2024
K070062 DIESSE DIAGNOSTICA SENESE S.P.A COPROSET SALMONELLA AND SHIGELLA, URISET PRESERVATIVE TUBES AND SWAB SET GENERAL USE 07/30/2007
K983119 HDC CORP. ENTERO-TEST HP, MODEL #102-01 03/15/1999
K003761 MEDICAL PACKAGING CORP. NAT - NUCLEIC ACID TRANSPORT 05/31/2001
K103805 MEDICAL WIRE & EQUIPMENT COMPANY (BATH) LTD MEDICAL WIRE & EQUIPMENT S-TRANSWAB (OR SIGMA-TRANSWAB) LIQUID AMIES COLLECTION AND TRANSPORT DEVICE 01/25/2011
K082472 MEDICAL WIRE & EQUIPMENT COMPANY (BATH) LTD VIROCULT, MODEL MW950 12/30/2008
K964144 PARA SCIENTIFIC CO. PARACON PLUS FORMALIN - PCP-F, PARACON PLUS SAF - PCP-SAF AND PARACON PLUS MF - PCP-MF 11/27/1996
K131630 PURITAN MEDICAL PRODUCTS LLC PURITAN AMIES MEDIUM COLLECTION AND TRANSPORT SYSTEM 10/21/2013
K120846 PURITAN MEDICAL PRODUCTS LLC TRANSPORT CULTURE MEDIUM DEVICE 06/08/2012
K013711 REMEL CO. BACTI-SWAB DRY 11/26/2001
K981391 REMEL, INC. PAR-ONE 07/14/1998
K964026 SAGE PRODUCTS, INC. STP SYSTEM - SAF 11/07/1996
K963986 SAGE PRODUCTS, INC. STP SYSTEM PVA WITH ZINC 11/08/1996
K964027 SAGE PRODUCTS, INC. STP SYSTEM-PVA WITH MERCURY 11/01/1996
K960997 STARPLEX SCIENTIFIC, INC. STARSWAB CULTURE COLLECTION AND TRANSPORT SYSTEM 04/03/1996


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