FDA applicant
Abbott Molecular, Inc.
FDA records 33 decisions for Abbott Molecular, Inc. (Des Plaines, IL) from 1998 to 2025: 18 510(k) clearances, 1 De Novo grant and 14 original PMA approvals. Most are in product codes MZP (Assay, Hybridization And/Or Nucleic Acid…) and PAB (Cytomegalovirus (Cmv) Dna Quantitative Assay). Since 2016 its 510(k)s took a median of 246 days from receipt to decision, against 252 for FDA’s reviews in the same codes and years. Its devices cite 24 predicates, 7 of them its own earlier devices. 18 recalls are linked to its devices.
FDA’s records also spell it “Abbott Molecular”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Abbott Molecular, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
6in 2025
2026 so far, outlined.
Recalls per year
2in 2024
Class I Class II/III not classified
Planning a device like Abbott Molecular, 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.