MODIFICATION TO ROCHE ELECSYS FOLATE II CALCHECK II— 510(k) K043320

Name: FDA 510(k) clearance K043320
Creator: U.S. Food and Drug Administration
Published: 2004-12-17

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K043320 for MODIFICATION TO ROCHE ELECSYS FOLATE II CALCHECK II, Substantially Equivalent on 2004-12-17. Applicant: Roche Diagnostics Corp.. Device class: 1.

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code JJX
Device class: Class 1
Regulation: 21 CFR 862.1660
Advisory panel: Clinical Chemistry
Date received: 2004-12-02
Decision date: 2004-12-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code JJX

product code JJX

Other: 2
Total: 2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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