CREATININE PLUS— 510(k) K003261

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K003261 for CREATININE PLUS, Substantially Equivalent on 2000-11-16. Applicant: Roche Diagnostics Corp.. Device class: 2.

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code JFY
Device class: Class 2
Regulation: 21 CFR 862.1225
Advisory panel: Clinical Chemistry
Date received: 2000-10-18
Decision date: 2000-11-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K003261

K-number listed on FDA's recall record

Z-1923-2015 — Creatinine Plus ver. 2. Intended for use on COBAS INTEGRA systems , cobas c111, and cobas c systems for the quantitative determination of the creatinine concentration in serum, plasma, and urine.Class II·Terminated·Roche Diagnostics Operations, Inc.·20150507

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K003261.

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