The following data is part of a premarket notification filed by Becton Dickinson And Company (bd) with the FDA for Bd Vacutainer Rapid Serum Tube Plus Blood Collection Tube, Model 368771.
| Device ID | K091292 |
| 510k Number | K091292 |
| Device Name: | BD VACUTAINER RAPID SERUM TUBE PLUS BLOOD COLLECTION TUBE, MODEL 368771 |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | BECTON DICKINSON AND COMPANY (BD) 1 BECTON DRIVE. MC300 Franklin Lakes, NJ 07417 -1885 |
| Contact | Mary Ann Alsberge |
| Correspondent | Mary Ann Alsberge BECTON DICKINSON AND COMPANY (BD) 1 BECTON DRIVE. MC300 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 | 2009-05-04 |
| Decision Date | 2009-08-25 |
| Summary: | summary |