The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Vacutainer Brand Safety Blood Collection Assembly(multiple).
| Device ID | K972404 |
| 510k Number | K972404 |
| Device Name: | VACUTAINER BRAND SAFETY BLOOD COLLECTION ASSEMBLY(MULTIPLE) |
| Classification | Flask, Tissue Culture |
| Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC ONE BECTON DR. Franklin Lakes, NJ 07417 -1880 |
| Contact | John Schalago |
| Correspondent | John Schalago BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC ONE BECTON DR. Franklin Lakes, NJ 07417 -1880 |
| Product Code | KJA |
| CFR Regulation Number | 864.2240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-26 |
| Decision Date | 1997-07-22 |
| Summary: | summary |