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U.S. Department of Health and Human Services

510(k) Premarket Notification
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81 to 90 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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br monitor and br monitor calibrators on the access immunoassay systems, model 387620, 387647 BECKMAN COULTER, INC. K033036 02/03/2004
brahms diagnostica lumitest trak human BRAHMS DIAGNOSTICA, LLC. K033454 03/22/2004
btg smartest glucose test system BT MEDICAL K032029 12/18/2003
bun reagent for beckman synchron cx & cx delta reagent DIAMOND DIAGNOSTICS, INC. K033056 01/30/2004
c. difficile toxin a + b fecal antigen detection microwell elisa kit model; cdiff-96 IVD RESEARCH, INC. K032897 05/27/2004
calibrating material, calibrating standards DIAMOND DIAGNOSTICS, INC. K033060 03/04/2004
calibrating material, ise electrolyte reference DIAMOND DIAGNOSTICS, INC. K033061 11/07/2003
camp multiple analyte enzyme immunoassay, cat.# 0510, 0511 (500 & 5000 test kits) Lin-Zhi International, Inc. K033866 04/07/2004
captia hsv 1 igg type specific elisa kit TRINITY BIOTECH USA K033105 07/13/2004
captia hsv 2 igg type specific elisa kit TRINITY BIOTECH USA K033106 07/13/2004

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