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International Technidyne Corporation

7 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Integrated Data Management System - Version 7.1, 7.2 and 7.3; ITC Corporation, 8 Olsen Pla recall (Z-2438-2010)International Technidyne Corporation2010-09-20
GEM Check Coag CNTRL Normal APTT Whole Blood Controls Package Insert: IVD. 15/pk. 06260061 recall (Z-2107-2010)International Technidyne Corporation2010-07-28
GEM Check Coag CNTRL Abnormal APTT Whole Blood Controls Package Insert; IVD. 06260060100. recall (Z-2108-2010)International Technidyne Corporation2010-07-28
directCHECK Whole Blood Control; for Hemochron J. Microcoagulation Systems. recall (Z-1786-2010)International Technidyne Corporation2010-06-11
ProTime Microcoagulation System Instrument, Catalogue Number: PROTIMEPRO, International Te recall (Z-0546-2008)International Technidyne Corporation2008-01-25
ProTime Microcoagulation System Instrument, Catalogue Number: PROTIMEPST, International Te recall (Z-0547-2008)International Technidyne Corporation2008-01-25
ProTime Microcoagulation System Instrument:Catalogue Number: PROTIMEINT, International Tec recall (Z-0548-2008)International Technidyne Corporation2008-01-25

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Every clearance here is in the API, with alerts when new ones post.