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U.S. Department of Health and Human Services

510(k) Premarket Notification
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71 to 80 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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bd probetec et legionella pneumophila (lp) amplified dna assay BECTON, DICKINSON & CO. K033861 03/09/2004
benzodiazepine enzyme immunoassay Lin-Zhi International, Inc. K032365 09/05/2003
binax now rsv test, model 430-000 and binax now nasopharyngeal swab accessory pack, model 400-065 BINAX, INC. K032166 10/21/2003
bindazyme clq cic eia kit THE BINDING SITE, LTD. K031563 09/10/2003
bindazyme human anti-phosphatidylserine iga, igg and igm enzyme immunoassay kit THE BINDING SITE, LTD. K032240 09/29/2003
biocentrex cardiac panel BIOCENTREX K033155 01/12/2004
bmbp enzyme immunoassay, cat #0610, 0611 (500, 5000 test kit) Lin-Zhi International, Inc. K033885 05/19/2004
borrelia burgdorferi igg/igm elisa test system TRINITY BIOTECH USA K033083 11/26/2003
borrelia burgdorferi igm elisa test system TRINITY BIOTECH USA K033070 11/26/2003
boston biomedica, inc. borrelia burgdorferi igm and igg BOSTON BIOMEDICA, INC. K032713 11/24/2003

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