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FDA 510(k)

CHROMID MRSA AGAR, MODEL: REF 43 841

K-Number: K091024 · 2009-07-17

ApplicantbioMerieux, Inc.
Decision Date2009-07-17
Product CodeJSO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CHROMID MRSA AGAR, MODEL: REF 43 841 is the device name listed in this FDA 510(k) record. The listed applicant is bioMerieux, Inc.. It received FDA 510(k) clearance on 2009-07-17 under 510(k) number K091024. 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 CHROMID MRSA AGAR, MODEL: REF 43 841?

CHROMID MRSA AGAR, MODEL: REF 43 841 is a medical device that received FDA 510(k) clearance on 2009-07-17. The listed applicant is bioMerieux, Inc.. The 510(k) number is K091024.

When did CHROMID MRSA AGAR, MODEL: REF 43 841 receive FDA 510(k) clearance?

CHROMID MRSA AGAR, MODEL: REF 43 841 received FDA 510(k) clearance on 2009-07-17, under 510(k) number K091024.

Who is the listed applicant for CHROMID MRSA AGAR, MODEL: REF 43 841?

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

What is the FDA product code for CHROMID MRSA AGAR, MODEL: REF 43 841?

The FDA product code for CHROMID MRSA AGAR, MODEL: REF 43 841 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.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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