Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
1 to 10 of 17 Results
ProductCode: JIX Applicant: ROCHE DIAGNOSTICS Decision Date To: 12/09/2016
 
 1 
 2 
 > 
Results per Page
New Search  
Export all 17 Records to ExcelExport to Excel | Download Files | More About 510(k)
Device Name
Sort by Device Name [A-Z]
Sort by Device Name [Z-A]
Applicant
Sort by Applicant [A-Z]
Sort by Applicant [Z-A]
510(K)
Number
Sort by 510(k) Number [0-9]
Sort by 510(k) Number [9-0]
Decision
Date
Sort by Decision Date [0-9]
Sort by Decision Date [9-0]
total protein urine/csf gen.3 Roche Diagnostics K071239 09/14/2007
roche diagnostics ck-mb ROCHE DIAGNOSTICS CORP. K003158 12/18/2000
roche diagnostics calibrator for automated systems, roche diagnostics calibrator calibrator for automated system Roche Diagnostics K101456 09/08/2010
precinorm proteins in urine/csf (puc) and precipath puc Roche Diagnostics K050026 01/31/2005
modification to calibrator for automatic systems (cfas) ROCHE DIAGNOSTICS CORP. K033501 11/20/2003
elecsys cortisol calcheck ROCHE DIAGNOSTICS CORP. K000576 03/21/2000
elecsys c-peptide calset ROCHE DIAGNOSTICS CORP. K033873 02/13/2004
elecsys anti-tpo calset Roche Diagnostics K103171 02/11/2011
cobas lithium ROCHE DIAGNOSTICS CORP. K063684 03/21/2008
calibrator for automated systems proteins in urine/csf ROCHE DIAGNOSTICS CORP. K040264 04/02/2004
-
-