PROADENO+ ASSAY— 510(k) K132159

Name: FDA 510(k) clearance K132159
Creator: U.S. Food and Drug Administration
Published: 2013-08-14

Substantially Equivalent

Gen-Probe Prodesse, Inc.

FDA 510(k) clearance K132159 for PROADENO+ ASSAY, Substantially Equivalent on 2013-08-14. Applicant: Gen-Probe Prodesse, Inc.. Device class: 2.

Clearance details

Applicant: Gen-Probe Prodesse, Inc.
Product code: Code OCC
Device class: Class 2
Regulation: 21 CFR 866.3980
Advisory panel: Microbiology
Date received: 2013-07-12
Decision date: 2013-08-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Waukesha, WI, US

Download summary PDF View 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, 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.