DeviceClearance

Panther Fusion Flu A/B/RSV Assay, Panther Fusion Universal Fluids Kit, Panther Fusion Assay Fluids I-S Kit, Panther Fusion Specimen Lysis Tubes— 510(k) K171963

Substantially Equivalent

Hologic, Inc.

FDA 510(k) clearance K171963 for Panther Fusion Flu A/B/RSV Assay, Panther Fusion Universal Fluids Kit, Panther Fusion Assay Fluids I-S Kit, Panther Fusion Specimen Lysis Tubes, Substantially Equivalent on 2017-09-26. Applicant: Hologic, Inc.. Device class: 2.

Clearance details

Applicant
Hologic, Inc.
Product code
Code OCC
Device class
Class 2
Regulation
21 CFR 866.3980
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
San Diego, CA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code OCC

product code OCC
Death
3
Malfunction
706
Total
709

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K171963

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K171963.

Data sourced from openFDA. This site is unofficial and independent of the FDA.