510(k) K190553
K190553 is an FDA 510(k) premarket notification submitted by Hardy Diagnostics for the device "HardyCHROM CRE". The FDA issued a decision of Substantially Equivalent on April 29, 2019. The device falls under product code JSO (Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar), a Class II device regulated under 21 CFR 866.1700. Hardy Diagnostics has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 29, 2019
- Date Received
- March 5, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
- Device Class
- Class II
- Regulation Number
- 866.1700
- Review Panel
- MI
- Submission Type