HardyCHROM ESBL
K-Number: K160512 · 2016-11-15
ApplicantHardy Diagnostics
Decision Date2016-11-15
Product CodeJSO
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
HardyCHROM ESBL is a medical device manufactured by Hardy Diagnostics. It received FDA 510(k) clearance on 2016-11-15 under approval number K160512. The device is classified under product code JSO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the HardyCHROM ESBL?
HardyCHROM ESBL is a medical device that received FDA 510(k) clearance on 2016-11-15. It is manufactured by Hardy Diagnostics. The 510(k) number is K160512.
When was HardyCHROM ESBL approved by the FDA?
HardyCHROM ESBL received FDA 510(k) clearance on 2016-11-15, under approval number K160512.
What company makes HardyCHROM ESBL?
HardyCHROM ESBL is manufactured by Hardy Diagnostics.
What is the FDA product code for HardyCHROM ESBL?
The FDA product code for HardyCHROM ESBL is JSO.
Other Devices by Hardy Diagnostics
Related Devices (Code: JSO)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.