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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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athena multi-lite rheumatoid factor igm test system ZEUS SCIENTIFIC, INC. K033802 02/27/2004
audit microcontrols microfd bnp control AALTO SCIENTIFIC LTD. K032122 09/09/2003
autokit total ketone bodies kit (serum) and wako ketone body calibrator WAKO CHEMICALS, USA, INC. K033860 04/23/2004
autostat ii anti-tisue transglutaminase iga elisa HYCOR BIOMEDICAL LTD. K033744 01/20/2004
axsym cortisol assay FUJIREBIO DIAGNOSTICS, INC. K033731 02/20/2004
barbiturate enzyme immunoassay, ca. # 0140 (500 tests kit); cat# 0141 (5000 tests kit) Lin-Zhi International, Inc. K032764 11/03/2003
bayer advia centaur automated chemiluminescence analyzer BAYER HEALTHCARE, LLC K032525 09/09/2003
bayer advia digoxin assay for the integrated module system BAYER DIAGNOSTICS CORP. K033007 11/14/2003
bayer clinitek status analyzer BAYER HEALTHCARE, LLC K031947 12/19/2003
bayer rapidlab 1200 system BAYER HEALTHCARE, LLC K031560 12/17/2003

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