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FDA 510(k)

ROMA Calculation Tool Using Elecsys Assays

K-Number: K153607 · 2016-06-15

ApplicantRoche Diagnostics
Decision Date2016-06-15
Product CodeONX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ROMA Calculation Tool Using Elecsys Assays is a medical device manufactured by Roche Diagnostics. It received FDA 510(k) clearance on 2016-06-15 under approval number K153607. The device is classified under product code ONX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROMA Calculation Tool Using Elecsys Assays?

ROMA Calculation Tool Using Elecsys Assays is a medical device that received FDA 510(k) clearance on 2016-06-15. It is manufactured by Roche Diagnostics. The 510(k) number is K153607.

When was ROMA Calculation Tool Using Elecsys Assays approved by the FDA?

ROMA Calculation Tool Using Elecsys Assays received FDA 510(k) clearance on 2016-06-15, under approval number K153607.

What company makes ROMA Calculation Tool Using Elecsys Assays?

ROMA Calculation Tool Using Elecsys Assays is manufactured by Roche Diagnostics.

What is the FDA product code for ROMA Calculation Tool Using Elecsys Assays?

The FDA product code for ROMA Calculation Tool Using Elecsys Assays is ONX.

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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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