Cleared Traditional

cobas u 601 urinalysis test system

K183432 · Roche Diagnostics · Chemistry
May 2019
Decision
147d
Days
Class 2
Risk

About This 510(k) Submission

K183432 is an FDA 510(k) clearance for the cobas u 601 urinalysis test system, a Method, Enzymatic, Glucose (urinary, Non-quantitative) (Class II — Special Controls, product code JIL), submitted by Roche Diagnostics (Indianapolos, US). The FDA issued a Cleared decision on May 7, 2019, 147 days after receiving the submission on December 11, 2018. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1340.

Submission Details

510(k) Number K183432 FDA.gov
FDA Decision Cleared SESE
Date Received December 11, 2018
Decision Date May 07, 2019
Days to Decision 147 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JIL — Method, Enzymatic, Glucose (urinary, Non-quantitative)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1340

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