510(k) Report

FDA applicant

Ind Diagnostics, Inc.

Delta, B.C., CA2 decisions2011–20123 recalls

FDA records 2 decisions for Ind Diagnostics, Inc. (Delta, B.C., CA) from 2011 to 2012: 2 510(k) clearances. Most are in product codes KHE (Reagent, Occult Blood) and LCX (Kit, Test, Pregnancy, Hcg, Over The Counter). 3 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, hematology panel, where it files most

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

FDA decisions per year

1in 2012

2011: 12012: 1
2011high 1 (2011) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

3in 2023

2023: 3
2011high 3 (2023) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — Ind Diagnostics, Inc. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • KHEReagent, Occult Blood1decision
  • LCXKit, Test, Pregnancy, Hcg, Over The Counter1decision

What has FDA decided for it lately?

  • K113506Ind One Step Occult Blood (Fob) TestInd Diagnostics, Inc. · 2012
  • K110889Ind One Step HCG Urine Pregnancy Test (Strip)Ind Diagnostics, Inc. · 20113 recalls

All 2 as Ind Diagnostics, Inc. →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K110889One Step Pregnancy Test REF 100-01May 22, 2023Class II
  • K110889PrestiBio Pregnancy Strips REF 100-4 25 HCG Test StripsMay 22, 2023Class II
  • K110889PrestiBio Ovulation and Pregnancy Strips REF 100-4 and REF 200-4 60 LH Test Strips/+30…May 22, 2023Class II