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

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..

Clearance details

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

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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.