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U.S. Department of Health and Human Services

510(k) Premarket Notification
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1 to 7 of 7 Results
ProductCode: DFH Applicant: THE BINDING SITE, LTD. Decision Date To: 06/01/2024
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freelite human kappa and lambda free diagnostic test kits for use on the roche cobas integra 400/400 plus analyzer kit THE BINDING SITE, LTD. K070900 11/30/2007
freelite human kappa and lambda free kits for use on the spaplus analyzer THE BINDING SITE, LTD. K062372 06/21/2007
freelite human kappa and lambda free kits for use on the bayer advia 1650 analyzer THE BINDING SITE, LTD. K051915 09/06/2005
freelite human kappa and lambda kits THE BINDING SITE, LTD. K040009 03/11/2004
freelite human kappa and human lambda free kits for use on the hitachi 911/912 analyzer THE BINDING SITE, LTD. K023009 01/21/2003
kappa immage freelite kit THE BINDING SITE, LTD. K003669 02/01/2001
sheep anti-human kappa free light chain immunofixation grade kit THE BINDING SITE, LTD. K002564 10/26/2000
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