510(k) K152800
K152800 is an FDA 510(k) premarket notification submitted by Meridian Bioscience, Inc. for the device "illumigene Mycoplasma DNA Amplification Assay". The FDA issued a decision of Substantially Equivalent on October 23, 2015. The device falls under product code OZX (Mycoplasma Pneumoniae Dna Assay System), a Class II device regulated under 21 CFR 866.3980. Meridian Bioscience, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 23, 2015
- Date Received
- September 28, 2015
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mycoplasma Pneumoniae Dna Assay System
- Device Class
- Class II
- Regulation Number
- 866.3980
- Review Panel
- MI
- Submission Type
A qualitative in vitro diagnostic assay intended to detect Mycoplasma pneumoniae DNA extracted from human respiratory specimens. Detection of Mycoplasma pneumoniae DNA aids in the diagnosis of Mycoplasma pneumoniae respiratory infection in conjunction with other clinical and laboratory testing in patients exhibiting signs and symptoms of upper respiratory tract infection.