FDI LEVEL I AND LEVEL II GLUCOSE CONTROLS FOR THE EMBRACE NO CODE— 510(k) K133197

Substantially Equivalent

Fujirebio Diagnostics,Inc.

FDA 510(k) clearance K133197 for FDI LEVEL I AND LEVEL II GLUCOSE CONTROLS FOR THE EMBRACE NO CODE, Substantially Equivalent on 2014-01-17. Applicant: Fujirebio Diagnostics,Inc..

Clearance details

Applicant: Fujirebio Diagnostics,Inc.
Product code: Code JJX
Advisory panel: Clinical Chemistry
Date received: 2013-10-17
Decision date: 2014-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seguin, TX, 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.