FDA applicant
Vivascience, Inc.
FDA records 3 decisions for Vivascience, Inc. (Acton, MA) from 1995 to 1996: 3 510(k) clearances. All are in product code JJH (Clinical Sample Concentrator). 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 Vivascience, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Vivascience, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Vivascience, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report