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FDA 510(k)

chromID MRSA

K-Number: K151688 · 2016-03-11

ApplicantbioMerieux, Inc.
Decision Date2016-03-11
Product CodeJSO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

chromID MRSA is a medical device manufactured by bioMerieux, Inc.. It received FDA 510(k) clearance on 2016-03-11 under approval number K151688. 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?

chromID MRSA is a medical device that received FDA 510(k) clearance on 2016-03-11. It is manufactured by bioMerieux, Inc.. The 510(k) number is K151688.

When was chromID MRSA approved by the FDA?

chromID MRSA received FDA 510(k) clearance on 2016-03-11, under approval number K151688.

What company makes chromID MRSA?

chromID MRSA is manufactured by bioMerieux, Inc..

What is the FDA product code for chromID MRSA?

The FDA product code for chromID MRSA is JSO.

Other Devices by bioMerieux, Inc.

K162076chromID MRSA K161227VITEK 2 AST-GN Cefepime (<=0.12->=32 ug/mL) K160911VIDAS B.R.A.H.M.S. PCT (PCT) K152075VITEK 2 AST-Gram Negative Ertapenem (<=0.12 - >=8 ug/mL) K151923VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL) K151817VITEK 2 AST-YS Caspofungin <=0.125 - >=8 ug/mL

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Related Devices (Code: JSO)

K160512HardyCHROM ESBLHardy Diagnostics K162076chromID MRSAbioMerieux, Inc. K171061MRSASelect IIBio-Rad K162620Remel Spectra ESBLRemel, Inc. K181092CHROMID CARBA agar (CARB)Biomerieux S.A. K190553HardyCHROM CREHardy Diagnostics

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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