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 Blood/Plasma Collection Device For Dna Testing
510(k) Number K972075
Device Name VACUTAINER BRAND PPT PLASMA PREPARATION TUBE
Applicant
Becton Dickinson Vacutainer Systems
One Becton Dr.
Franklin Lake,  NJ  07417
Applicant Contact JOHN SCHALAGO
Correspondent
Becton Dickinson Vacutainer Systems
One Becton Dr.
Franklin Lake,  NJ  07417
Correspondent Contact JOHN SCHALAGO
Regulation Number862.1675
Classification Product Code
PJE  
Date Received06/03/1997
Decision Date 02/24/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-