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- MiscellaneousMiscellaneous
- Subpart B—Biological StainsCFR Sub-Part
- Subpart B—Clinical Chemistry Test SystemsCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- JSOCulture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar2Product Code
- JTNSusceptibility Test Discs, Antimicrobial2Product Code
- K241060HardyDisk AST Cefiderocol 30µg (FDC30)2Cleared 510(K)
- K231806Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF52Cleared 510(K)
- K232276Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD202Cleared 510(K)
- K231568HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20)2Cleared 510(K)
- K230651BD BBL™ Sensi-Disc™ Lefamulin 20µg (LMU-20)2Cleared 510(K)
- K230827HardyDisk AST Rezafungin 5µg (RZF5)2Cleared 510(K)
- K221826BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30)2Cleared 510(K)
- K203336Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC302Cleared 510(K)
- K210873Thermo Scientific Oxoid Lefamulin Disc (20µg) LMU202Cleared 510(K)
- K203700Thermo Scientific Oxoid Cefiderocol Disc (30 µg) FDC302Cleared 510(K)
Show All 320 Submissions
- JTTSusceptibility Test Powders, Antimicrobial2Product Code
- JTZCulture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth2Product Code
- JWYManual Antimicrobial Susceptibility Test Systems2Product Code
- LIEReagent/Device, Inoculum Calibration2Product Code
- LKACulture Media, Antimicrobial Susceptibility Test2Product Code
- LONSystem, Test, Automated, Antimicrobial Susceptibility, Short Incubation2Product Code
- LOPSolution, Antimicrobial2Product Code
- LRGInstrument For Auto Reader & Interpretation Of Overnight Suscept. Systems2Product Code
- LTTPanels, Test, Susceptibility, Antimicrobial2Product Code
- LTWSusceptibility Test Cards, Antimicrobial2Product Code
- LTXDiscs, Elution2Product Code
- MJASusceptibility Test Powders, Antimycobacterial2Product Code
- MJDCulture Media, Antimycobacteria, Susceptibility Test2Product Code
- MJECulture Media, Antifungal, Susceptibility Test2Product Code
- MYISystem, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies2Product Code
- NGZSusceptibility Test Plate, Antifungal2Product Code
- NIJSystem, Test, Genotypic Detection, Resistant Markers, Enterococcus Species2Product Code
- NQXSystem, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen2Product Code
- PMYSystem, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony2Product Code
- POCSystem, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen2Product Code
- PTJPhenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates2Product Code
- QIVCulture-Based Short-Term Incubation Antimicrobial Resistance Assay2Product Code
- Subpart C—Clinical Laboratory InstrumentsCFR Sub-Part
- Subpart C—Microbiology DevicesCFR Sub-Part
- Subpart D—Serological ReagentsCFR Sub-Part
- Subpart F—Immunological Test SystemsCFR Sub-Part
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HardyDisk AST Rezafungin 5µg (RZF5)
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K230827
- 510(k) Type
- Traditional
- Applicant
- Hardy Diagnostics
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 6/1/2023
- Days to Decision
- 66 days
- Submission Type
- Statement