FDA applicant
International Technidyne Corp.
FDA records 48 decisions for International Technidyne Corp. (Edison, NJ) from 1983 to 2013: 48 510(k) clearances. Most are in product codes JPA (System, Multipurpose For In Vitro Coagulation…) and GJS (Test, Time, Prothrombin). Its devices cite 12 predicates, 9 of them its own earlier devices. 20 recalls are linked to its devices.
FDA’s records also spell it “International Technidyne Corporation”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided International Technidyne Corp.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2013
2026 so far, outlined.
Recalls per year
1in 2026
Class I Class II/III not classified
Planning a device like International Technidyne Corp.’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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