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
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Test, Natriuretic Peptide
510(k) Number K072437
Device Name ELECSYS PROBNP II, PRECICONTROL CARDIAC II, PROBNP II CALSET
Applicant
Roche Diagnostics
9115 Hague Rd.
Indianapolis,  IN  46250 -0416
Applicant Contact KAY TAYLOR
Correspondent
Roche Diagnostics
9115 Hague Rd.
Indianapolis,  IN  46250 -0416
Correspondent Contact KAY TAYLOR
Regulation Number862.1117
Classification Product Code
NBC  
Subsequent Product Codes
JIT   JJY  
Date Received08/23/2007
Decision Date 02/05/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-