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 tubes, vials, systems, serum separators, blood collection
510(k) Number K153309
FOIA Releasable 510(k) K153309
Device Name BD Vacutainer UltraTouch Push Button Blood Collection Set
Applicant
BECTON, DICKINSON AND COMPANY
1 BECTON DRIVE
FRANKLIN LAKES,  NJ  07417
Applicant Contact Pasquale Amato
Correspondent
BECTON, DICKINSON AND COMPANY
1 BECTON DRIVE
FRANKLIN LAKES,  NJ  07417
Correspondent Contact Pasquale Amato
Regulation Number862.1675
Classification Product Code
JKA  
Subsequent Product Code
FPA  
Date Received11/17/2015
Decision Date 02/12/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-