FDA applicant
Genea Biomedx Pty, Ltd.
FDA records 6 decisions for Genea Biomedx Pty, Ltd. (Sydney, AU) from 2017 to 2018: 6 510(k) clearances. Most are in product codes MQL (Media, Reproductive) and MQG (Accessory, Assisted Reproduction). Since 2016 its 510(k)s took a median of 223 days from receipt to decision, against 113 for FDA’s reviews in the same codes and years. Its devices cite 9 predicates, 2 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Genea Biomedx Pty, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2018
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2017.
Planning a device like Genea Biomedx Pty, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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