510(k) K071101
K071101 is an FDA 510(k) premarket notification submitted by Meridian Bioscience, Inc. for the device "TRU RSV". The FDA issued a decision of Substantially Equivalent on October 18, 2007. The device falls under product code GOG (Antisera, Cf, Poliovirus 1-3), a Class I device regulated under 21 CFR 866.3405. Meridian Bioscience, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 18, 2007
- Date Received
- April 19, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antisera, Cf, Poliovirus 1-3
- Device Class
- Class I
- Regulation Number
- 866.3405
- Review Panel
- MI
- Submission Type