ELECSYS CA 19-9 IMMUNOASSAY, ELECSYS CA 19-9 CALSET— 510(k) K050231

Name: FDA 510(k) clearance K050231
Creator: U.S. Food and Drug Administration
Published: 2005-07-06

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K050231 for ELECSYS CA 19-9 IMMUNOASSAY, ELECSYS CA 19-9 CALSET, Substantially Equivalent on 2005-07-06. Applicant: Roche Diagnostics Corp.. Device class: 2.

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code JIT
Device class: Class 2
Regulation: 21 CFR 862.1150
Advisory panel: Clinical Chemistry
Date received: 2005-01-26
Decision date: 2005-07-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K050231

K-number listed on FDA's recall record

Z-1444-2020 — Elecsys CA 19-9, Cat. No. 07027028190 - Product Usage: the product is an immunoassay for monitoring and management of pancreatic cancerClass II·Terminated·Roche Diagnostics Operations, Inc.·20200207

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K050231.

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