JBAIDS INFLUENZA A&B DETECTION KIT— 510(k) K111775

Substantially Equivalent

U.S. Army Medical Material Development Acitvity

FDA 510(k) clearance K111775 for JBAIDS INFLUENZA A&B DETECTION KIT, Substantially Equivalent on 2011-09-13. Applicant: U.S. Army Medical Material Development Acitvity.

Clearance details

Applicant: U.S. Army Medical Material Development Acitvity
Product code: Code OCC
Advisory panel: Microbiology
Date received: 2011-06-23
Decision date: 2011-09-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Detrick, MD, 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.