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

FDA 510(k) Number Applicant Device Name Decision Date
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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