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LIO — Device, Specimen Collection Class I

FDA Device Classification

Classification Details

Product Code
LIO
Device Class
Class I
Regulation Number
866.2900
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K222613arx sciencesARX Liquid Amies Collection & Transport SystemMarch 27, 2024
K131630puritan medical productsPURITAN AMIES MEDIUM COLLECTION AND TRANSPORT SYSTEMOctober 21, 2013
K120846puritan medical productsTRANSPORT CULTURE MEDIUM DEVICEJune 8, 2012
K103805medical wire and equipment company (bath)MEDICAL WIRE & EQUIPMENT S-TRANSWAB (OR SIGMA-TRANSWAB) LIQUID AMIES COLLECTION January 25, 2011
K082472medical wire and equipment company (bath)VIROCULT, MODEL MW950December 30, 2008
K070062diesse diagnostica seneseCOPROSET SALMONELLA AND SHIGELLA, URISET PRESERVATIVE TUBES AND SWAB SET GENERALJuly 30, 2007
K013711remelBACTI-SWAB DRYNovember 26, 2001
K003761medical packagingNAT - NUCLEIC ACID TRANSPORTMay 31, 2001
K983119hdcENTERO-TEST HP, MODEL #102-01March 15, 1999
K981391remelPAR-ONEJuly 14, 1998
K964144para scientificPARACON PLUS FORMALIN - PCP-F, PARACON PLUS SAF - PCP-SAF AND PARACON PLUS MF - November 27, 1996
K963986sage productsSTP SYSTEM PVA WITH ZINCNovember 8, 1996
K964026sage productsSTP SYSTEM - SAFNovember 7, 1996
K964027sage productsSTP SYSTEM-PVA WITH MERCURYNovember 1, 1996
K960997starplex scientificSTARSWAB CULTURE COLLECTION AND TRANSPORT SYSTEMApril 3, 1996
K953929trinity laboratoriesMID-STREAM COLLECTION SET-STERILENovember 16, 1995
K950096evergreen industriesPINWORM EGG COLLECTORApril 5, 1995
K931383remelZINC PVAJune 15, 1993
K931770meridian diagnosticsPARA-PAK PLUSJune 15, 1993
K930313apex medical technologiesAPEX SPECIMEN BAGMarch 18, 1993