HardyDisk AST Omadacycline 30µg (OMC30)— 510(k) K183298
Substantially EquivalentHardy Diagnostics
FDA 510(k) clearance K183298 for HardyDisk AST Omadacycline 30µg (OMC30), Substantially Equivalent on 2019-01-18. Applicant: Hardy Diagnostics. Device class: 2.
Clearance details
- Applicant
- Hardy Diagnostics
- Product code
- Code JTN
- Device class
- Class 2
- Regulation
- 21 CFR 866.1620
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Maria, CA, US
Recent devices under product code JTN
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