cobas u 601 urinalysis test system— 510(k) K183432

Clearance details

Applicant

Roche Diagnostics

Product code

Code JIL

Device class

Class 2

Regulation

21 CFR 862.1340

Advisory panel

Clinical Chemistry

Date received

2018-12-11

Decision date

2019-05-07

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Indianapolis, IN, US

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• Z-0266-2022 — Cobas u 601 urinalysis test system, Catalog number 06334601001 The cobas U 601 urinalysis test system is comprised of the cobas u 601 urine analyzer and the cobas u pack. The cobas u 601 urine analyzer when used with the cobas u pack is a fully automated urinalysis system intended for the in vitro qualitative or semi-quantitative determination of urine analytes, including pH, leukocytes, nitrite, protein, glucose, ketones, urobilinogen, bilirubin, color and erythrocytes, as well as clarity.Class II·Terminated·Roche Diagnostics Operations, Inc.·20211018

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K183432.