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 Sirolimus Test System
510(k) Number K081857
Device Name DIMENSION SIRO FLEX REAGENT CARTRIDGE AND DIMENSION SIROLIMUS CALBIRATOR, MODELS DR 306, DC 306
Applicant
Siemens Healthcare Diagnostics Inc.
PO BOX 6101
NEWARK,  DE  19714 -6101
Applicant Contact GEORGE M PLUMMER
Correspondent
Siemens Healthcare Diagnostics Inc.
PO BOX 6101
NEWARK,  DE  19714 -6101
Correspondent Contact GEORGE M PLUMMER
Regulation Number862.3840
Classification Product Code
NRP  
Subsequent Product Code
DLJ  
Date Received07/01/2008
Decision Date 10/30/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-