The following data is part of a premarket notification filed by Becton Dickinson Vacutainer Systems with the FDA for Vacutainer Brand Pst Plasma Separation Tube.
Device ID | K954592 |
510k Number | K954592 |
Device Name: | VACUTAINER BRAND PST PLASMA SEPARATION TUBE |
Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
Applicant | BECTON DICKINSON VACUTAINER SYSTEMS ONE BECTON DR. Franklin Lakes, NJ 07417 -1885 |
Contact | Denise Duchene |
Correspondent | Denise Duchene BECTON DICKINSON VACUTAINER SYSTEMS ONE BECTON DR. Franklin Lakes, NJ 07417 -1885 |
Product Code | JKA |
CFR Regulation Number | 862.1675 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-10-02 |
Decision Date | 1995-11-28 |