FDA applicant
Spectrascience, Inc.
FDA records 2 decisions for Spectrascience, Inc. (Minnetonka, MN) from 1996 to 1997: 2 510(k) clearances. All are in product code FCL (Forceps, Biopsy, Non-Electric). 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 Spectrascience, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Spectrascience, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Spectrascience, Inc.’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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