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U.S. Department of Health and Human Services

510(k) Premarket Notification
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31 to 40 of 500 Results *
Decision Date From: 8/1/2003 Decision Date To: 04/23/2024 In Vitro Products: Yes
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audit(r) microlq(tm) serum protein control AALTO SCIENTIFIC LTD. K112705 01/24/2012
audit microcontrols linearity drop lq blood glucose AALTO SCIENTIFIC, LTD. K161874 08/10/2016
audit microcontrols linearity fd tumor markers ii Aalto Scientific, Ltd. K163629 03/10/2017
audit microcontrols linearity lq cystatin-c AALTO SCIENTIFIC, LTD. K143571 01/23/2015
clearinse cts specimen collection and transport system Aardvark Medical, Inc. K221664 07/03/2023
daptomycin AB BIODISK K042392 12/13/2004
etest doripenem - antimicrobial susceptibility test - mic at 0.002-32 ug/ml AB BIODISK K081325 07/24/2008
etest for antifungal suscepttibility testing AB BIODISK K040560 07/27/2004
etest for gemifloxacin AB BIODISK K042390 11/19/2004
etest tigecycline gram positive and gram negative aerobic bacteria, streptococcus spp. and anaerobic bacteria AB BIODISK K052366 10/13/2005

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