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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 the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2019-05-07 under 510(k) 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. The listed applicant is Roche Diagnostics. The 510(k) number is K183432.

When did cobas u 601 urinalysis test system receive FDA 510(k) clearance?

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

Who is the listed applicant for cobas u 601 urinalysis test system?

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

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.

Other records listing Roche Diagnostics as applicant

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Related Devices (Code: JIL)

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.

K193514AUTION MAX AX-4060 Urinalysis SystemArkray, Inc.K173327DIP/U.S. Urine Analysis Test SystemHealthy.Io, Ltd.K180356inui In-Home Urine Analysis Test SystemScanadu, Inc.K181024DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent StripsDFI Co., Ltd.K171521DUS R-50S (Urine Chemistry system)DFI Co., Ltd.K171083iChemVELOCITY Automated Urine Chemistry SystemIris Diagnostics, A Division of Iris International, 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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