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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Hardy Diagnostics. It received FDA 510(k) clearance on 2016-11-15 under 510(k) 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. The listed applicant is Hardy Diagnostics. The 510(k) number is K160512.

When did HardyCHROM ESBL receive FDA 510(k) clearance?

HardyCHROM ESBL received FDA 510(k) clearance on 2016-11-15, under 510(k) number K160512.

Who is the listed applicant for HardyCHROM ESBL?

The FDA 510(k) record lists Hardy Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HardyCHROM ESBL?

The FDA product code for HardyCHROM ESBL is JSO.

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Related Devices (Code: JSO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K190553HardyCHROM CREHardy DiagnosticsK181092CHROMID CARBA agar (CARB)Biomerieux S.A.K171061MRSASelect IIBio-RadK162620Remel Spectra ESBLRemel, Inc.K162076chromID MRSAbioMerieux, Inc.K151688chromID MRSAbioMerieux, Inc.

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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