FDA applicant
Abbott Diagnostics Scarborough, Inc.
FDA records 8 decisions for Abbott Diagnostics Scarborough, Inc. (Scarborough, ME) from 1996 to 2026: 7 510(k) clearances and 1 original PMA approval. Most are in product codes OCC (Respiratory Virus Panel Nucleic Acid Assay…) and QVF (Simple Point-Of-Care Device To Directly Detect…). Since 2016 its 510(k)s took a median of 61 days from receipt to decision, against 134 for FDA’s reviews in the same codes and years. Its devices cite 11 predicates, 4 of them its own earlier devices. 4 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Abbott Diagnostics Scarborough, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
4in 2025
Class I Class II/III not classified
Planning a device like Abbott Diagnostics Scarborough, 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) ReportOther applicant names beginning “Abbott”
FDA records each applicant name separately; these may or may not be the same firm.