HardyDisk AST Tebipenem 10µg (TBP10)— 510(k) K262113
Substantially EquivalentHardy Diagnostics
FDA 510(k) clearance K262113 for HardyDisk AST Tebipenem 10µg (TBP10), Substantially Equivalent on 2026-08-20. Applicant: Hardy Diagnostics. Device class: 2.
Summary
Hardy Diagnostics filed HardyDisk AST Tebipenem 10µg, listed as TBP10, under product code JTN, antimicrobial susceptibility test discs. The record doesn't expand AST.
Class II, 21 CFR 866.1620. Microbiology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Hardy Diagnostics filed from Santa Maria, California. The decision came 58 calendar days after receipt (June 23 to August 20, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Hardy Diagnostics
- Product code
- Product 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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