FDA applicant
King Diagnostics, Inc.
FDA records 41 decisions for King Diagnostics, Inc. (Indianapolis, IN) from 1981 to 1993: 41 510(k) clearances. Most are in product codes JPA (System, Multipurpose For In Vitro Coagulation…) and JIS (Calibrator, Primary). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided King Diagnostics, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for King Diagnostics, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like King Diagnostics, 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 “King”
FDA records each applicant name separately; these may or may not be the same firm.