FDA applicant
Immunodiagnostic Systems, Ltd.
FDA records 27 decisions for Immunodiagnostic Systems, Ltd. (Boldon, Tyne & Wear, GB) from 1994 to 2026: 27 510(k) clearances. Most are in product codes MRG (System, Test, Vitamin D) and JJX (Single (Specified) Analyte Controls (Assayed…). Since 2016 its 510(k)s took a median of 138 days from receipt to decision, against 127 for FDA’s reviews in the same codes and years. Its devices cite 16 predicates, 8 of them its own earlier devices. 2 recalls are linked to its devices.
FDA’s records also spell it “Immunodiagnostic Systems Limited”, “Immunodiagnostic Systems, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Immunodiagnostic Systems, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
1in 2012
Class I Class II/III not classified
Planning a device like Immunodiagnostic Systems, Ltd.’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