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FDA 510(k)

cobas u 601 urinalysis test system

K-Number: K183432 · 2019-05-07

ApplicantRoche Diagnostics
Decision Date2019-05-07
Product CodeJIL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

cobas u 601 urinalysis test system is a medical device manufactured by Roche Diagnostics. It received FDA 510(k) clearance on 2019-05-07 under approval number K183432. The device is classified under product code JIL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the cobas u 601 urinalysis test system?

cobas u 601 urinalysis test system is a medical device that received FDA 510(k) clearance on 2019-05-07. It is manufactured by Roche Diagnostics. The 510(k) number is K183432.

When was cobas u 601 urinalysis test system approved by the FDA?

cobas u 601 urinalysis test system received FDA 510(k) clearance on 2019-05-07, under approval number K183432.

What company makes cobas u 601 urinalysis test system?

cobas u 601 urinalysis test system is manufactured by Roche Diagnostics.

What is the FDA product code for cobas u 601 urinalysis test system?

The FDA product code for cobas u 601 urinalysis test system is JIL.

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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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