The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Bd Directigen Flu A+b.
| Device ID | K001364 |
| 510k Number | K001364 |
| Device Name: | BD DIRECTIGEN FLU A+B |
| Classification | Devices Detecting Influenza A, B, And C Virus Antigens |
| Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 7 LOVETON CIRCLE Sparks, MD 21152 -0999 |
| Contact | Monica Giguere |
| Correspondent | Monica Giguere BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 7 LOVETON CIRCLE Sparks, MD 21152 -0999 |
| Product Code | PSZ |
| CFR Regulation Number | 866.3328 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-01 |
| Decision Date | 2000-06-28 |