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U.S. Department of Health and Human Services

510(K) Premarket Notification
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510(K)
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powder free vinyl patient examination gloves, clear (non-colored) JEWEL PLASTIC CO., LTD. k130809 02/18/2014
axiom reg ANTHOGYR SAS k131066 02/21/2014
ace -gt reagent; ace lipase ragent; ace t4 reagent ALFA WASSERMANN k131515 08/14/2013
sterican cannula B. BRAUN MEDICAL, INC. k131842 08/20/2013
neria soft 90 infusion set UNOMEDICAL A/S k132142 10/08/2013
liquichek immunoassay premium control-trilevel, liquichek immunoassay premium control-level i, liquichek immunoassay Bio-Rad Laboratories k132227 10/25/2013
accutip cover ACCUTOME, INC. k132549 04/23/2014
mpact extension MEDACTA INTERNATIONAL k132879 01/22/2014
immulite 2000; hcg calibration verification material, insulin calibration verification material, pyrilinks-d calibration Siemens Healthcare Diagnostics Inc. k133128 10/22/2013
e-fit ef-1280 ems machine FIT-PRO KFT LTD. k133225 10/24/2014

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