510(k) K023556
K023556 is an FDA 510(k) premarket notification submitted by Thermo Biostar, Inc. for the device "FLU OIA A/B TEST KIT". The FDA issued a decision of Substantially Equivalent on March 27, 2003. 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. Thermo Biostar, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 27, 2003
- Date Received
- October 23, 2002
- Clearance Type
- Traditional
- 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.