The following data is part of a premarket notification filed by Genzyme Corp. with the FDA for Osom Influenza A&b Test.
| Device ID | K061508 |
| 510k Number | K061508 |
| Device Name: | OSOM INFLUENZA A&B TEST |
| Classification | Devices Detecting Influenza A, B, And C Virus Antigens |
| Applicant | GENZYME CORP. ONE KENDALL SQUARE Cambridge, MA 02139 |
| Contact | Fred D Lasky |
| Correspondent | Fred D Lasky GENZYME CORP. ONE KENDALL SQUARE Cambridge, MA 02139 |
| Product Code | PSZ |
| CFR Regulation Number | 866.3328 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-01 |
| Decision Date | 2006-06-12 |
| Summary: | summary |