The following data is part of a premarket notification filed by Genzyme Corp. with the FDA for Genzyme Osom Influenza A & B Test.
Device ID | K051244 |
510k Number | K051244 |
Device Name: | GENZYME OSOM INFLUENZA A & B TEST |
Classification | Devices Detecting Influenza A, B, And C Virus Antigens |
Applicant | GENZYME CORP. 500 KENDALL STREET Cambridge, MA 02142 |
Contact | Fred D Lasky |
Correspondent | Fred D Lasky GENZYME CORP. 500 KENDALL STREET Cambridge, MA 02142 |
Product Code | PSZ |
CFR Regulation Number | 866.3328 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-05-16 |
Decision Date | 2006-02-21 |
Summary: | summary |