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FDA 510(k)

CHROMID CARBA agar (CARB)

K-Number: K181092 · 2018-07-06

ApplicantBiomerieux S.A.
Decision Date2018-07-06
Product CodeJSO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CHROMID CARBA agar (CARB) is the device name listed in this FDA 510(k) record. The listed applicant is Biomerieux S.A.. It received FDA 510(k) clearance on 2018-07-06 under 510(k) number K181092. 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 CARBA agar (CARB)?

CHROMID CARBA agar (CARB) is a medical device that received FDA 510(k) clearance on 2018-07-06. The listed applicant is Biomerieux S.A.. The 510(k) number is K181092.

When did CHROMID CARBA agar (CARB) receive FDA 510(k) clearance?

CHROMID CARBA agar (CARB) received FDA 510(k) clearance on 2018-07-06, under 510(k) number K181092.

Who is the listed applicant for CHROMID CARBA agar (CARB)?

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

What is the FDA product code for CHROMID CARBA agar (CARB)?

The FDA product code for CHROMID CARBA agar (CARB) is JSO.

Other records listing Biomerieux S.A. as applicant

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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 DiagnosticsK171061MRSASelect 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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