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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 10 of 85 Results
Applicant: BIO-RAD LABORATORIES, INC. Decision Date To: 10/04/2022
 
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qxdx bcr-abl %is kit for use on the qxdx autodg ddpcr system Bio-Rad Laboratories, Inc. K181661 02/13/2019
hemoglobin variants system on newborn hemoglobin system with gdm and hbreview software Bio-Rad Laboratories, Inc. K171664 09/13/2017
d-10 hemoglobin a1c program BIO-RAD LABORATORIES, INC. K161687 10/14/2016
d-100 hba1c, d-100 hba1c calibrator pack Bio-Rad Laboratories, Inc. K151321 12/09/2015
variant ii turbo hba1c kit - 2.0 Bio-Rad Laboratories, Inc. K142448 03/24/2015
variant ii turbo link hemoglobin a1c program/testing system BIO-RAD LABORATORIES, INC. K140801 06/25/2014
bioplex 2200 celiac iga and igg kits on the bioplex 2200 system, bioplex 2200 celiac iga and igg calibrator sets, and bi BIO-RAD LABORATORIES, INC. K130053 09/19/2013
variant(tm) ii turbo hba1c kit - 2.0 BIO-RAD LABORATORIES, INC., CLINICAL SYSTEMS DIVIS K130990 05/09/2013
liquichek pediatric control, level 1; liquichek pediatric contol, level 2; liquichek pediatric control, bilevel minipak BIO-RAD LABORATORIES, INC. K130963 05/06/2013
variant ii hemoglobin a1c program (new), variant ii hemoglobin testing system with cdm software, cdm software BIO-RAD LABORATORIES, INC., CLINICAL SYSTEMS DIVIS K130860 04/25/2013
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