510(k) K172621
K172621 is an FDA 510(k) premarket notification submitted by Hardy Diagnostics for the device "HardyDisk Meropenem/Vaborbactam 20/10µg (MEV30)". The FDA issued a decision of Substantially Equivalent on October 3, 2017. The device falls under product code JTN (Susceptibility Test Discs, Antimicrobial), a Class II device regulated under 21 CFR 866.1620. Hardy Diagnostics has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 3, 2017
- Date Received
- August 31, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Susceptibility Test Discs, Antimicrobial
- Device Class
- Class II
- Regulation Number
- 866.1620
- Review Panel
- MI
- Submission Type