510(k) K092633
K092633 is an FDA 510(k) premarket notification submitted by Genzyme Corporation for the device "OSOM INFLUENZA A&B TEST , MODEL PN190". The FDA issued a decision of Substantially Equivalent on September 25, 2009. The device falls under product code PSZ (Devices Detecting Influenza A, B, And C Virus Antigens), a Class II device regulated under 21 CFR 866.3328. Genzyme Corporation has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 25, 2009
- Date Received
- August 27, 2009
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Devices Detecting Influenza A, B, And C Virus Antigens
- Device Class
- Class II
- Regulation Number
- 866.3328
- Review Panel
- MI
- Submission Type
An influenza virus antigen detection test system is a device intended for the qualitative detection of influenza viral antigens directly from clinical specimens in patients with signs and symptoms of respiratory infection.