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U.S. Department of Health and Human Services

510(k) Premarket Notification
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ProductCode: JJY Applicant: ROCHE DIAGNOSTICS CORP. Decision Date To: 03/29/2024
 
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ammonia/ethanol/co2 calibrator, control normal, control abnormal ROCHE DIAGNOSTICS CORP. K031880 07/16/2003
cobas integra ceruloplasmin ROCHE DIAGNOSTICS CORP. K062379 01/31/2007
elecsys ca 19-9 calcheck ROCHE DIAGNOSTICS CORP. K051185 07/06/2005
elecsys cortisol test system ROCHE DIAGNOSTICS CORP. K000270 03/07/2000
elecsys precicontrol anemia ROCHE DIAGNOSTICS CORP. K051517 07/05/2005
elecsys precicontrol bone ROCHE DIAGNOSTICS CORP. K051543 10/17/2005
elecsys precicontrol multianalyte ROCHE DIAGNOSTICS CORP. K033937 01/07/2004
elecsys precicontrol universal ROCHE DIAGNOSTICS CORP. K051687 07/25/2005
elecsys shbg immunoassay ROCHE DIAGNOSTICS CORP. K031717 08/05/2003
modification to precinorm universal plus and precipath universal plus control sera ROCHE DIAGNOSTICS CORP. K042389 09/14/2004
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