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

FDA 510(k) Number Applicant Device Name Decision Date
K900225 ADEZA BIOMEDICAL ROMCHECK SPECIMEN COLLECTION KIT 02/02/1990
K851387 ANALYTICAL LUMINESCENCE LABORATORY, INC. MICROSTATIC URINE TRANSPORT TUBE FOR C & S 05/20/1985
K930313 APEX MEDICAL TECHNOLOGIES, INC. APEX SPECIMEN BAG 03/18/1993
K920761 BIO MEDICUS, INC. URINE CULTUR STABILIZATION TRANSPORT TUBE 06/19/1992
K871860 BIO-RAD NOVAPATH C. TRACHOMATIS DIRECT SPEC COLLECTION KIT 05/29/1987
K884342 BIO-RAD NOVAPATH SPECIMEN COLLECTION KIT 11/03/1988
K862607 BOOTS-CELLTECH DIAGNOSTICS, INC. IMAGEN(TM) CHLAMYDIA SPECIMEN COLLECTION KIT 08/04/1986
K833814 CONCORD LABORATORIES, INC. SANI CATCH BA 03/19/1984
K851378 DIAGNON CORP. VIRTRAN VIRAL TRANPORTER 06/21/1985
K893905 DIAGNOSTIC PRODUCTS CORP. PATHODX(TM) CHLAMYDIA DIRECT SPECIMEN (PDCY1) 08/03/1989
K070062 DIESSE DIAGNOSTICA SENESE S.P.A COPROSET SALMONELLA AND SHIGELLA, URISET PRESERVATIVE TUBES AND SWAB SET GENERAL USE 07/30/2007
K832246 E.I. DUPONT DE NEMOURS & CO., INC. DUPONT ISOLATOR 1.5 MICROBIAL TUBE 09/26/1983
K950096 EVERGREEN INDUSTRIES, INC. PINWORM EGG COLLECTOR 04/05/1995
K890134 EVERGREEN SCIENTIFIC, INC. FTK FECAL TRANSPORT KIT 04/21/1989
K905120 GIBSON LABORATORIES, INC. SAF FIXATIVE 12/17/1990
K983119 HDC CORP. ENTERO-TEST HP, MODEL #102-01 03/15/1999
K843000 HML INC/BIOTECHNOLOGY TRANSFER MICRO ORGANISM GROWTH SYS-M1000 02/06/1985
K882485 INTL. CANCER SCREENING LABORATORIES, INC. DIVERSI-KIT 07/18/1988
K820520 INTL. RESEARCH DISTRIBUTORS, INC. VD ALERT 05/14/1982
K870963 KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. MODIFIED PATHFINDER SPECIMEN COLLECTION KIT 04/08/1987
K881125 KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. PATHFINDER(TM) CHLAMYDIA EIA BRUSH COLLECTION KIT 03/23/1988
K840799 M.G. LABORATORIES, INC. V.D.T.-GONORRHEA TEST KIT 06/07/1984
K903405 MEDICAL LABORATORY AUTOMATION SYSTEMS, INC. CHLAMYDIA ACCU-CULSHURE TM 10/16/1990
K903638 MEDICAL LABORATORY AUTOMATION SYSTEMS, INC. GASTRO-INTESTINAL ACCU-CULSHURE TM 01/18/1991
K903406 MEDICAL LABORATORY AUTOMATION SYSTEMS, INC. VIRAL ACCU-CULSHURE TM 10/16/1990
K915454 MEDICAL PACKAGING CORP. CHLAMYDIA TRACHOMATIS SPECIMEN COLLECTION KIT 04/08/1992
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
K931770 MERIDIAN DIAGNOSTICS, INC. PARA-PAK PLUS 06/15/1993
K920536 MICROPROBE CORP. AFFIRM VP SAMPLE COLLECTION SET 07/30/1992
K873565 MOLECULAR BIOSYSTEMS, INC. SNAP(R) ROTAVIRUS DIAGNOSTIC KIT 05/13/1988
K870231 NCS DIAGNOSTICS, INC. KULTSURE 02/04/1987
K860655 NCS DIAGNOSTICS, INC. KULTSURE (CATALOGUE NO. M200) 03/06/1986
K872751 PARA SCIENTIFIC CO. FLUORTRAN - C(TM) 07/23/1987
K964144 PARA SCIENTIFIC CO. PARACON PLUS FORMALIN - PCP-F, PARACON PLUS SAF - PCP-SAF AND PARACON PLUS MF - PCP-MF 11/27/1996
K840086 PREVENTIVE DIAGNOSTICS CORP. PRESERV MF FIXATIVE 15ML 01/30/1984
K834566 PREVENTIVE DIAGNOSTICS CORP. PRESERV SAF FIXATIVE 15ML 02/04/1984
K924329 PRO-LAB DIAGNOSTICS TRANSYSTEM AMIES W/O CHARCOAL 12/24/1992
K924330 PRO-LAB DIAGNOSTICS TRANSYSTEM AMIES WITH CHARCOAL 12/24/1992
K924328 PRO-LAB DIAGNOSTICS TRANSYSTEM LIQUID AMIES MEDIUM 12/24/1992
K924331 PRO-LAB DIAGNOSTICS TRANSYSTEM LIQUID STUART MEDIUM 12/24/1992
K924053 PROTEINS INTL., INC. CYTOQUANT COMBINED TRANSPORT MEDIA 01/15/1993
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
K864727 R.P. LABORATORIES, INC. CULT-UR 01/05/1987
K013711 REMEL CO. BACTI-SWAB DRY 11/26/2001
K912831 REMEL CO. BACTI-SWAB(TM) II 07/30/1991
K912832 REMEL CO. BACTI-SWAB(TM) NPG 08/22/1991
K931383 REMEL CO. ZINC PVA 06/15/1993
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
K832079 SYVA CO. COLLECTION KIT CHLAMYDIA TRACHOMATIS 09/29/1983
K843935 SYVA CO. MODIFICATION MICROTRAK DIRECT SPECIMEN TEST 10/23/1984
K874456 TM & M C/O BURDITT,BOWLES,RADZIUS & RUBERRY, LTD. CHLAMYDIA STAT DIRECT SMEAR COLLECTION KIT 11/24/1987
K953929 TRINITY LABORATORIES, INC. MID-STREAM COLLECTION SET-STERILE 11/16/1995
K902467 WADLEY BIOSCIENCES CORP. FLORA-STAT URINE TRANSPORT SYSTEM 08/22/1990
K896794 WESTMARK, STERILE PACKING SYSTEMS, INC. (SPS) SPECIMEN CONTAINER 03/01/1990
K854719 XSIRIUS SCIENTIFIC, INC. LUNG CARE (SPECIMEN TRANSPORT & STORAGE CONTAINER) 02/24/1986


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