510(k) Report

FDA applicant

Pearce Clinical Laboratories, Inc.

Conroe, TX3 decisions1987–19880 recalls

FDA records 3 decisions for Pearce Clinical Laboratories, Inc. (Conroe, TX) from 1987 to 1988: 3 510(k) clearances. Most are in product codes DXN (System, Measurement, Blood-Pressure…) and KHE (Reagent, Occult Blood). 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, cardiovascular panel, where it files most

How often FDA has decided Pearce Clinical Laboratories, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Pearce Clinical Laboratories, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Pearce Clinical Laboratories, 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?

  • DXNSystem, Measurement, Blood-Pressure, Non-Invasive1decision
  • KHEReagent, Occult Blood1decision
  • JILMethod, Enzymatic, Glucose (Urinary, Non-Quantitative)1decision

What has FDA decided for it lately?

  • K874180Colorectal Cancer Risk Detector (TM)Pearce Clinical Laboratories, Inc. · 1988
  • K864544Diabetes Risk DetectorPearce Clinical Laboratories, Inc. · 1987
  • K871482Hypertension Risk Detector (TM)Pearce Clinical Laboratories, Inc. · 1987

All 3 as Pearce Clinical Laboratories, Inc. →