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FDA 510(k)

HARDYCHROM MRSA

K-Number: K102922 · 2011-05-04

ApplicantHardy Diagnostics
Decision Date2011-05-04
Product CodeJSO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

HARDYCHROM MRSA is the device name listed in this FDA 510(k) record. The listed applicant is Hardy Diagnostics. It received FDA 510(k) clearance on 2011-05-04 under 510(k) number K102922. 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 MRSA?

HARDYCHROM MRSA is a medical device that received FDA 510(k) clearance on 2011-05-04. The listed applicant is Hardy Diagnostics. The 510(k) number is K102922.

When did HARDYCHROM MRSA receive FDA 510(k) clearance?

HARDYCHROM MRSA received FDA 510(k) clearance on 2011-05-04, under 510(k) number K102922.

Who is the listed applicant for HARDYCHROM MRSA?

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 MRSA?

The FDA product code for HARDYCHROM MRSA is JSO.

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Other records listing Hardy Diagnostics as applicant

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.

K262113HardyDisk AST Tebipenem 10µg (TBP10)K260842HardyDisk AST Gepotidacin 10µg (GEP10)K253105HardyDisk AST Cefiderocol 30µg (FDC30)K250956HardyDisk AST Gepotidacin 10µg (GEP10)K250454HardyDisk Aztreonam/Avibactam 30/20µg (AZA50)K233534Viral Transport Medium

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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.K160512HardyCHROM ESBLHardy DiagnosticsK162076chromID 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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