VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR RIFAMPIN— 510(k) K042946

Clearance details

Applicant

bioMerieux, Inc.

Product code

Code LON

Device class

Class 2

Regulation

21 CFR 866.1645

Advisory panel

Microbiology

Date received

2004-10-26

Decision date

2004-12-07

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Hazelwood, MO, US

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Malfunction

2,383

Total

2,383

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 →