The following data is part of a premarket notification filed by Becton, Dickinson And Company with the FDA for Bd Vacutainer Barricor Lithium Heparin Plasma Blood Collection Tube.
Device ID | K160657 |
510k Number | K160657 |
Device Name: | BD Vacutainer Barricor Lithium Heparin Plasma Blood Collection Tube |
Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
Applicant | BECTON, DICKINSON AND COMPANY 1 BECTON DRIVE Franklin Lakes, NJ 07417 |
Contact | Branden Reid |
Correspondent | Branden Reid BECTON, DICKINSON AND COMPANY 1 BECTON DRIVE Franklin Lakes, NJ 07417 |
Product Code | JKA |
CFR Regulation Number | 862.1675 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-03-08 |
Decision Date | 2016-09-23 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
50382903650472 | K160657 | 000 |
50382903650465 | K160657 | 000 |
50382903650458 | K160657 | 000 |
50382903650441 | K160657 | 000 |
50382903650434 | K160657 | 000 |