The following data is part of a premarket notification filed by Becton Dickinson & Co. with the FDA for Bd Vacutainer Trace Element Serum Plus Tube And Bd Vacutainer Trace Element K2edta Plus Tube, Models 368380/368381.
| Device ID | K041071 |
| 510k Number | K041071 |
| Device Name: | BD VACUTAINER TRACE ELEMENT SERUM PLUS TUBE AND BD VACUTAINER TRACE ELEMENT K2EDTA PLUS TUBE, MODELS 368380/368381 |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | BECTON DICKINSON & CO. 1 Becton Drive Franklin Lakes, NJ 07417 |
| Contact | Jing Zhang |
| Correspondent | Jing Zhang BECTON DICKINSON & CO. 1 Becton Drive Franklin Lakes, NJ 07417 |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-26 |
| Decision Date | 2004-05-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50382903683814 | K041071 | 000 |
| 50382903683807 | K041071 | 000 |