510(k) Report

FDA applicant

Amtec Diagnostics International, Inc.

Conroe, TX2 decisions1987–19880 recalls

FDA records 2 decisions for Amtec Diagnostics International, Inc. (Conroe, TX) from 1987 to 1988: 2 510(k) clearances. Most are in product codes DCK (C-Reactive Protein, Antigen, Antiserum, And…) and DHR (System, Test, Rheumatoid Factor). 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 Amtec Diagnostics International, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Amtec Diagnostics International, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Amtec Diagnostics International, 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?

  • DCKC-Reactive Protein, Antigen, Antiserum, And Control1decision
  • DHRSystem, Test, Rheumatoid Factor1decision

What has FDA decided for it lately?

  • K882998Acute Phase C-Reactive Protein Latex Agglu. TestAmtec Diagnostics International, Inc. · 1988
  • K873064Amtec Rheumatoid Factor Latex Agglutination KitAmtec Diagnostics International, Inc. · 1987

All 2 as Amtec Diagnostics International, Inc. →

Other applicant names beginning “Amtec”

FDA records each applicant name separately; these may or may not be the same firm.

Amtec Medical 1