FDA applicant
Diagnostic Chemicals, Ltd.
FDA records 66 decisions for Diagnostic Chemicals, Ltd. (Charlottetown, P.E.I., CA) from 1994 to 2007: 66 510(k) clearances. Most are in product codes DIC (Alcohol Dehydrogenase, Specific Reagent For…) and LDP (Colorimetry, Acetaminophen). Its devices cite 8 predicates, 1 of them its own earlier devices. 8 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Diagnostic Chemicals, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2007
2026 so far, outlined.
Recalls per year
1in 2016
Class I Class II/III not classified
Planning a device like Diagnostic Chemicals, 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) ReportOther applicant names beginning “Diagnostic”
FDA records each applicant name separately; these may or may not be the same firm.