The following data is part of a premarket notification filed by Genzyme Corporation with the FDA for Osom Influenza A&b Test , Model Pn190.
| Device ID | K092633 |
| 510k Number | K092633 |
| Device Name: | OSOM INFLUENZA A&B TEST , MODEL PN190 |
| Classification | Devices Detecting Influenza A, B, And C Virus Antigens |
| Applicant | GENZYME CORPORATION 500 KENDALL STREET Cambridge, MA 02142 |
| Contact | Fil Buenviaje |
| Correspondent | Fil Buenviaje GENZYME CORPORATION 500 KENDALL STREET Cambridge, MA 02142 |
| Product Code | PSZ |
| CFR Regulation Number | 866.3328 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-27 |
| Decision Date | 2009-09-25 |
| Summary: | summary |