JBAIDS Influenza A & B Detection Kit— 510(k) K152523

Substantially Equivalent

U.S Army Medical Materiel Development Activity

FDA 510(k) clearance K152523 for JBAIDS Influenza A & B Detection Kit, Substantially Equivalent on 2015-10-01. Applicant: U.S Army Medical Materiel Development Activity.

Clearance details

Applicant: U.S Army Medical Materiel Development Activity
Product code: Code OCC
Advisory panel: Microbiology
Date received: 2015-09-03
Decision date: 2015-10-01
Decision: Substantially Equivalent
Clearance type: Special
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.