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U.S. Department of Health and Human Services

510(k) Premarket Notification

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41 to 50 of 500 Results *
Decision Date From: 8/1/2003 Decision Date To: 04/23/2024 In Vitro Products: Yes
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510(K)
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etest moxifloxacin 0.002-32 ug/ml AB BIOMERIEUX K093604 08/25/2010
etest voriconazole 0.002-32 ug/ml AB BIOMERIEUX K082534 11/02/2009
piccolo c-reactive protein (crp) test system ABAXIS, INC. K091052 01/15/2010
piccolo hdl-capillary test system ABAXIS, INC. K120662 04/24/2012
piccolo lactate dephydrogenase test system ABAXIS, INC. K051108 07/08/2005
piccolo lactate test system ABAXIS, INC. K130113 03/11/2013
piccolo magnesium test system ABAXIS, INC. K040115 01/30/2004
piccolo magnesium test system ABAXIS, INC. K091910 10/01/2009
piccolo potassium test system Abaxis, Inc. K200865 10/20/2021
piccolo total cholesterol - capillary test system ABAXIS, INC. K130200 02/15/2013

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