FILMARRAY RESPIRATORY PANEL (RP)— 510(k) K103175

Substantially Equivalent

Idaho Technology, Inc.

FDA 510(k) clearance K103175 for FILMARRAY RESPIRATORY PANEL (RP), Substantially Equivalent on 2011-02-17. Applicant: Idaho Technology, Inc..

Clearance details

Applicant: Idaho Technology, Inc.
Product code: Code OCC
Advisory panel: Microbiology
Date received: 2010-10-28
Decision date: 2011-02-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

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Adverse events under product code OCC

product code OCC

Death: 3
Malfunction: 706
Total: 709

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.