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FDA 510(k)

HardyCHROM CRE

K-Number: K190553 · 2019-04-29

ApplicantHardy Diagnostics
Decision Date2019-04-29
Product CodeJSO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

HardyCHROM CRE is a medical device manufactured by Hardy Diagnostics. It received FDA 510(k) clearance on 2019-04-29 under approval number K190553. 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 CRE?

HardyCHROM CRE is a medical device that received FDA 510(k) clearance on 2019-04-29. It is manufactured by Hardy Diagnostics. The 510(k) number is K190553.

When was HardyCHROM CRE approved by the FDA?

HardyCHROM CRE received FDA 510(k) clearance on 2019-04-29, under approval number K190553.

What company makes HardyCHROM CRE?

HardyCHROM CRE is manufactured by Hardy Diagnostics.

What is the FDA product code for HardyCHROM CRE?

The FDA product code for HardyCHROM CRE is JSO.

Other Devices by Hardy Diagnostics

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Related Devices (Code: JSO)

K160512HardyCHROM ESBLHardy Diagnostics K162076chromID MRSAbioMerieux, Inc. K151688chromID MRSAbioMerieux, Inc. K171061MRSASelect IIBio-Rad K162620Remel Spectra ESBLRemel, Inc. K181092CHROMID CARBA agar (CARB)Biomerieux S.A.

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.

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