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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 10 of 10 Results
ProductCode: GJS Applicant: INSTRUMENTATION LABORATORY CO Decision Date To: 05/30/2020
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hemosil recombiplastin 2g (8 ml vial) INSTRUMENTATION LABORATORY CO. K132722 01/22/2014
hemosil readiplas tin INSTRUMENTATION LABORATORY CO. K122584 03/24/2013
hemosil recombiplastin 2g INSTRUMENTATION LABORATORY CO. K070005 08/15/2007
hemosil pt-fibrinogen hs plus INSTRUMENTATION LABORATORY CO. K060931 05/02/2006
hemosil recombiplastin INSTRUMENTATION LABORATORY CO. K043184 12/22/2004
hemosil recombi plastin INSTRUMENTATION LABORATORY CO. K012768 09/18/2001
il test pt-fibrinogen recombinant INSTRUMENTATION LABORATORY CO. K981479 07/07/1998
assess(tm) high abnormal control INSTRUMENTATION LABORATORY CO. K931118 03/30/1994
assess(tm) low abnormal control INSTRUMENTATION LABORATORY CO. K931117 03/30/1994
il test (tm) pt-fibrinogen hs plus INSTRUMENTATION LABORATORY CO. K933252 10/04/1993
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