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 K220212
Device Name BD Vacutainer® Push Button Blood Collection Set, BD Vacutainer® Push Button Blood Collection Set with Pre-Attached Holder
Applicant
Becton, Dickinson and Company
1 Becton Drive
Franklin Lakes,  NJ  07417
Applicant Contact Kelly Hilliger
Correspondent
Becton, Dickinson and Company
1 Becton Drive
Franklin Lakes,  NJ  07417
Correspondent Contact Kelly Hilliger
Regulation Number862.1675
Classification Product Code
JKA  
Subsequent Product Code
FPA  
Date Received01/26/2022
Decision Date 03/24/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-