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U.S. Department of Health and Human Services

510(K) Premarket Notification
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Device Name
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510(K)
Number
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Decision
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raichem bun rate reagent (liquid) Hemagen Diagnostics, Inc. k041051 06/30/2004
raichem ldh-p reagent w/separate start- Reagents Applications, Inc. k831419 06/16/1983
randox immunoassay premium plus control levels 1,2 and level 3 and immunoassay premium plus tri-level control Randox Laboratories Limited k140522 05/22/2014
rapid e Dms Laboratories k813609 02/04/1982
rd-2104 J.F. Jelenko & Co., Inc. k002222 08/31/2000
reddick trocar and cannula Ideal Medical, Inc. k911601 05/21/1991
rehastim 2, rehamove 2 Hasomed GmbH k112844 10/27/2011
reprocessed autosuture gia endoscopic staplers Sterilmed, Inc. k070930 10/18/2007
retro mirror Union Broach, Div. Moyco Industries, Inc. k941574 05/18/1994
revised battery charger Vickers America Medical Corp. k790689 05/29/1979

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