510(k) Report

FDA applicant

Ind Diagnostic, Inc.

Delta, B.C., CA8 decisions2003–20125 recalls

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, last Nov 3, 2026

FIG. A — Illustration, clinical chemistry panel, where it files most

How often FDA has decided Ind Diagnostic, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2007: 12010: 12012: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

4in 2023

2008: 12023: 4
2007high 4 (2023) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Ind Diagnostic, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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.

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