510(k) Report

FDA applicant

Hellen Professional Services

Northridge, CA2 decisions1998–20020 recalls

FDA records 2 decisions for Hellen Professional Services (Northridge, CA) from 1998 to 2002: 2 510(k) clearances. Most are in product codes MVE (Biosensor, Immunoassay, Myoglobin) and JWZ (Kit, Screening, Trichomonas). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, immunology panel, where it files most

How often FDA has decided Hellen Professional Services’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Hellen Professional Services since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Hellen Professional Services 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?

  • MVEBiosensor, Immunoassay, Myoglobin1decision
  • JWZKit, Screening, Trichomonas1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K020226Xenostrip-TV Trichomonas Diagnostic Test Kit; Catalog Numbers S1383.01, S1383.02 & S1383.03Hellen Professional Services · 20021cites it

What has FDA decided for it lately?

  • K020226Xenostrip-TV Trichomonas Diagnostic Test Kit; Catalog Numbers S1383.01, S1383.02 & S1383.03Hellen Professional Services · 2002
  • K981536Quantech Myoglobin AssayHellen Professional Services · 1998

All 2 as Hellen Professional Services →