510(k) Report

FDA applicant

International Newtech Development, Inc.

Delta, B.C., CA8 decisions1995–20009 recalls

FDA records 8 decisions for International Newtech Development, Inc. (Delta, B.C., CA) from 1995 to 2000: 8 510(k) clearances. Most are in product codes JHI (Visual, Pregnancy Hcg, Prescription Use) and LCX (Kit, Test, Pregnancy, Hcg, Over The Counter). 9 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 International Newtech Development, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for International Newtech Development, Inc. since 2007.

Recalls per year

9in 2023

2023: 9
2007high 9 (2023) · low 0 (2007)2026

Class I Class II/III not classified

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

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Which product codes does it file in?

  • JHIVisual, Pregnancy Hcg, Prescription Use5decisions
  • LCXKit, Test, Pregnancy, Hcg, Over The Counter1decision
  • JMTDiazo (Colorimetric), Nitrite (Urinary, Non-Quant)1decision
  • JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)1decision

Who builds on its devices?

Later devices cite its devices 2 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K974059One Step Midstream HCG Pregnancy TestInternational Newtech Development, Inc. · 19981cites it
  • K993850Urinalysis Reagent Strips (10 Parameters)International Newtech Development, Inc. · 20001cites it

What has FDA decided for it lately?

  • K993850Urinalysis Reagent Strips (10 Parameters)International Newtech Development, Inc. · 20002 recalls
  • K974059One Step Midstream HCG Pregnancy TestInternational Newtech Development, Inc. · 19983 recalls
  • K974060Ministrip/ Serum and Urine Combo HCG TestInternational Newtech Development, Inc. · 1998
  • K974009PS-Unit Cassette/Serum and Urine Combo HCGInternational Newtech Development, Inc. · 1998
  • K970176HCG ControlsInternational Newtech Development, Inc. · 1997
  • K963133PS-Unit Cassette/Serum HCGInternational Newtech Development, Inc. · 19961 recall
  • K963132Mini Strip/Serum HCGInternational Newtech Development, Inc. · 19963 recalls
  • K951705Ministrip HCGInternational Newtech Development, Inc. · 1995

All 8 as International Newtech Development, Inc. →

What has been recalled?

9 recalls linked to its devices; the latest:

  • K993850HealthyWiser UriTest" 10 Parameter Reagent Test Strips for Urinalysis REF 900-10May 22, 2023Class II
  • K974059PrestiBio Rapid Detection Pregnancy Test Midstream REF 100-17 3 TESTSMay 22, 2023Class II
  • K963132To Life hCG Pregnancy Urine Test Strips Format REF Cat No: 100-10May 22, 2023Class II
  • K974059DiagnosUS Pregnancy Test Midstream REF 100-17May 22, 2023Class II
  • K974059Am I Pregnant? One Step HCG Pregnancy Test REF 100-17May 22, 2023Class II
  • K963132Lem Fertility hCG Pregnancy Urine Test REF 100-12May 22, 2023Class II