The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Bbl Pneumoslide Test.
| Device ID | K821960 |
| 510k Number | K821960 |
| Device Name: | BBL PNEUMOSLIDE TEST |
| Classification | Antisera, All Types, Streptococcus Pneumoniae |
| Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1875 EYE ST. NW STE. 625 Washington, DC 20006 |
| Product Code | GWC |
| CFR Regulation Number | 866.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-07-01 |
| Decision Date | 1982-07-30 |