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

Clearance details

Applicant

Fujirebio Diagnostics,Inc.

Product code

Code JJX

Device class

Class 1

Regulation

21 CFR 862.1660

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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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 →