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International Technidyne Corp.

15 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Pro Time Microcoagulation System/ Pro Time 3 Cuvette, Pro3-4, Pro3-25, and Pro3-50. Intern recall (Z-0837-2013)International Technidyne Corp.2013-02-19
Hemochron JR. Microcoagulation Systems Prothrombin Time (PT). International Ethidine Corp recall (Z-2953-2011)International Technidyne Corp.2011-08-05
IL GEM PCL/PCL Plus - Gem Test PT Cartridge ITC-Nexus Dx A unitized mlcrocoagulation test recall (Z-2954-2011)International Technidyne Corp.2011-08-05
AVOXimeter 1000, AVOXimeter 4000 1000- portable bedside whole blood oximeter that directly recall (Z-2218-2011)International Technidyne Corp.2011-05-19
Hemochron Signature Elite Whole Blood Microcoagulation (IVD) System. The system is intende recall (Z-0893-2011)International Technidyne Corp.2011-03-01
Hemochron Whole Blood Coagulation Systems Activated Clotting Time (ACT); Package label sta recall (Z-1093-2011)International Technidyne Corp.2011-02-11
International Technidyne Corporation (ITC) directCheck Whole Blood Quality Controls Plasma recall (Z-2200-2010)International Technidyne Corp.2010-08-10
RQCHRT HRT Control Level 1 & 2; Whole Blood controls for use with Hemochron Kaolin and Cel recall (Z-2110-2010)International Technidyne Corp.2010-07-28
Hemochron Jr. ACT- LR Assay (JACT- LR); ITC Catalogue/Code Number: JACTLR 45 Cuvettes; For recall (Z-1732-2009)International Technidyne Corp.2009-08-21
International Technidyne Corp. (ITC) AVOXimeter 1000 Oximeter, Catalog Numbers: AVON1000-1 recall (Z-1237-2008)International Technidyne Corp.2008-08-06
International Technidyne Corp. (ITC) AVOXimeter 1000E Oximeter, Catalog Numbers: AVOX1000E recall (Z-1238-2008)International Technidyne Corp.2008-08-06
International Technidyne Corp. (ITC) AVOXimeter 4000 Co-oximeter, Catalog Numbers: AVOX400 recall (Z-1239-2008)International Technidyne Corp.2008-08-06
International Technidyne Corporation (ITC) ProTime Microcoagulation System Instrument-Cata recall (Z-0470-2007)International Technidyne Corp.2007-01-13
Tenderlett Adult Lancet, sterile, single use. Red trigger color with incision depth/length recall (Z-0673-06)International Technidyne Corp2006-03-23
Hemochron Jr. Whole Blood Microcoagulation system Low Range Activated Clotting Time. ACT-L recall (Z-1381-05)International Technidyne Corp.2005-08-23

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