The following data is part of a premarket notification filed by Becton, Dickinson & Company with the FDA for Blood Specimen Collection Devices - Vacuum.
Device ID | BK040030 |
510k Number | BK040030 |
Device Name: | Blood Specimen Collection Devices - Vacuum |
Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
Applicant | Becton, Dickinson & Company 1 Becton Drive, Mc 300 Franklin Lakes, NJ 07417 |
Product Code | JKA |
CFR Regulation Number | 862.1675 [🔎] |
Decision | Substantially Equivalent (SE) |
Type | 510(k) Traditio |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-04-09 |
Decision Date | 2004-05-05 |