FDA applicant
Ind Diagnostic, Inc.
FDA records 8 decisions for Ind Diagnostic, Inc. (Delta, B.C., CA) from 2003 to 2012: 8 510(k) clearances. Most are in product codes JHI (Visual, Pregnancy Hcg, Prescription Use) and CGJ (Radioimmunoassay, Follicle-Stimulating Hormone). 5 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Ind Diagnostic, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2012
2007high 1 (2007) · low 0 (2008)2026
2026 so far, outlined.
Recalls per year
4in 2023
2007high 4 (2023) · low 0 (2007)2026
Class I Class II/III not classified
Planning a device like Ind Diagnostic, 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) Report