510(k) K170127
K170127 is an FDA 510(k) premarket notification submitted by Hardy Diagnostics for the device "HardyDisk Ceftolozane/Tazobactam, (30/10 ug)-C/T40". The FDA issued a decision of Substantially Equivalent on Mar 14, 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 109 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 14, 2017
- Date Received
- Jan 13, 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
- 510(k)