• 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
-
91 to 100 of 500 Results *
Decision Date From: 8/1/2003 Decision Date To: 04/23/2024 In Vitro Products: Yes
 < 
 5 
 6 
 7 
 8 
 9 
 10 
 11 
 12 
 13 
 14 
 > 
Results per Page
New Search  
Export all 500 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]
abx pentra creatinine 120 cp, total protein 100 cp, multical, n and p controls, and urine control l/h HORIBA ABX K072115 11/30/2007
abx pentra creatinine 120 cp; abx pentra multical; abx pentra n control; abx pentra p control; abx pentra urine control HORIBA ABX S.A.S. K110530 04/30/2012
abx pentra dx 120: option sps evolution HORIBA ABX K050719 04/26/2005
abx pentra enzymatic creatinine cp, abx pentra multical, abx pentra n control, abx pentra p control, and abx pentra urin HORIBA ABX S.A.S. K110137 08/10/2011
abx pentra glucose hk cp, abx pentra uric acid cp, abx pentra urine control l/h HORIBA ABX K081276 09/12/2008
abx pentra glucose hk cp, urea cp, uric acid cp HORIBA ABX K070146 10/12/2007
abx pentra hba1c wb, calibrator, control and hemolysis reagent HORIBA ABX K073309 10/17/2008
abx pentra micro alb control l/h HORIBA ABX SAS K133676 07/11/2014
abx pentra tpu cal, model a11a01898 HORIBA ABX SAS K092570 10/16/2009
abx pentra urine cal HORIBA ABX K071779 03/05/2008

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