NUCLISENS EASYQ ENTEROVIRUS V1.1., NUCLISENS EASYQ DIRECTOR 2.6, NUCLISENS EASYQ ANALYZER, NUCLISENS MINIMAG— 510(k) K093383

Clearance details

Applicant

bioMerieux, Inc.

Product code

Code OOI

Device class

Class 2

Regulation

21 CFR 862.2570

Advisory panel

Clinical Chemistry

Date received

2009-10-30

Decision date

2010-07-06

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Durham, NC, US

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Malfunction

2,506

Other

3

Total

2,509

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 →