The following data is part of a premarket notification filed by Becton Dickinson & Co. with the FDA for Bd Directigen Ez Rsv Kit.
| Device ID | K022133 |
| 510k Number | K022133 |
| Device Name: | BD DIRECTIGEN EZ RSV KIT |
| Classification | Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus |
| Applicant | BECTON DICKINSON & CO. 7 LOVETON CIR. Sparks, MD 21152 -0999 |
| Contact | Colleen A Kistler |
| Correspondent | Colleen A Kistler BECTON DICKINSON & CO. 7 LOVETON CIR. Sparks, MD 21152 -0999 |
| Product Code | GQG |
| CFR Regulation Number | 866.3480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-01 |
| Decision Date | 2002-12-10 |
| Summary: | summary |