ROCHE DIAGNOSTICS URISYS 1100 URINE ANALYZER— 510(k) K033548

Name: FDA 510(k) clearance K033548
Creator: U.S. Food and Drug Administration
Published: 2003-11-24

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K033548 for ROCHE DIAGNOSTICS URISYS 1100 URINE ANALYZER, Substantially Equivalent on 2003-11-24. Applicant: Roche Diagnostics Corp.. Device class: 2.

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code KHE
Device class: Class 2
Regulation: 21 CFR 864.6550
Advisory panel: Hematology
Date received: 2003-11-12
Decision date: 2003-11-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K033548

K-number listed on FDA's recall record

Z-0301-2019 — Roche Diagnostics URISYS 1100 Urine Analyzer Part Number: 03617556001 Product Usage: The URISYS 1100 Urine Analyzer is a reflectance photometer designed to automatically read and evaluate the results of Chemstrip 5 OB, Chemstrip 7, Chemstrip 10 MD, and Chemstrip 10 UA urine test strips for various urine analytes.: specific gravity, pH, leukocytes, nitrite, protein, glucose, ketones, urobilinogen, bilirubin and bloodClass II·Terminated·Roche Diagnostics Corporation·20180924

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K033548.

Data sourced from openFDA. This site is unofficial and independent of the FDA.