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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 the device name listed in this FDA 510(k) record. The listed applicant is Hardy Diagnostics. It received FDA 510(k) clearance on 2019-04-29 under 510(k) 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. The listed applicant is Hardy Diagnostics. The 510(k) number is K190553.

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

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

Who is the listed applicant for HardyCHROM CRE?

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 CRE?

The FDA product code for HardyCHROM CRE 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.

K181092CHROMID CARBA agar (CARB)Biomerieux S.A.K171061MRSASelect IIBio-RadK162620Remel Spectra ESBLRemel, Inc.K160512HardyCHROM ESBLHardy DiagnosticsK162076chromID 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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