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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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510(K)
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akers laboratories inc. blood cell separator AKERS LABORATORIES, INC. K030815 09/17/2003
amedica drug screen mdma-bar-bzo-mtd-tca test AMEDICA BIOTECH, INC. K031497 10/17/2003
ammonia-l3k assay, catalogue number 233-10 DIAGNOSTIC CHEMICALS LTD. K033921 03/10/2004
amnisure fetal membranes rupture test model fmrt1 N-DIA, INC. K030849 02/02/2004
ariol APPLIED IMAGING CORP. K033200 03/18/2004
ariol her-2/neu ihc APPLIED IMAGING CORP. K031715 01/08/2004
arkit hba1c ARKRAY, INC. K030553 09/02/2003
atac direct bilirubin reagent and calibrator ELAN DIAGNOSTICS K030003 09/29/2003
atac hemoglobin a1c reagent kit CLINICAL DATA, INC. K031042 11/03/2003
atac total bilirubin reagent ELAN DIAGNOSTICS K030014 09/26/2003

*   The maximium 500 devices meeting your search criteria returned. Please narrow your search.
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