510(k) K113190
K113190 is an FDA 510(k) premarket notification submitted by Meridian Bioscience, Inc. for the device "TRU LEGIONELLA". The FDA issued a decision of Substantially Equivalent on February 24, 2012. The device falls under product code MJH (Legionella, Spp., Elisa), a Class II device regulated under 21 CFR 866.3300. Meridian Bioscience, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 24, 2012
- Date Received
- October 31, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Legionella, Spp., Elisa
- Device Class
- Class II
- Regulation Number
- 866.3300
- Review Panel
- MI
- Submission Type