The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Leucoprep Brand Tube.
| Device ID | K872775 |
| 510k Number | K872775 |
| Device Name: | LEUCOPREP BRAND TUBE |
| Classification | Lymphocyte Separation Medium |
| Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes, NJ 07417 -1880 |
| Contact | J Arnsberger |
| Correspondent | J Arnsberger BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes, NJ 07417 -1880 |
| Product Code | JCF |
| CFR Regulation Number | 864.8500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-07-14 |
| Decision Date | 1987-10-02 |