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 radioassay, vitamin b12
510(k) Number K920078
Device Name AFFINITY B12
Applicant
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
P.O. BOX 243
COCKEYSVILLE,  MD  21030 -0243
Applicant Contact JUDITH J SMITH
Correspondent
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
P.O. BOX 243
COCKEYSVILLE,  MD  21030 -0243
Correspondent Contact JUDITH J SMITH
Regulation Number862.1810
Classification Product Code
CDD  
Date Received01/08/1992
Decision Date 02/14/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-