510(k) Report

FDA applicant

Diamond Shamrock Corp.

Mchenry, IL2 decisions1976–19830 recalls

FDA records 2 decisions for Diamond Shamrock Corp. (Mchenry, IL) from 1976 to 1983: 2 510(k) clearances. Most are in product codes CGN (Acid, Folic, Radioimmunoassay) and KLK (Monitor, Oxygen, Cutaneous, For Infant Not…). 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, clinical chemistry panel, where it files most

How often FDA has decided Diamond Shamrock Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Diamond Shamrock Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Diamond Shamrock Corp. 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?

  • CGNAcid, Folic, Radioimmunoassay1decision
  • KLKMonitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia1decision

What has FDA decided for it lately?

  • K830197Transcutaneous Blood Oxygen Sensor SysDiamond Shamrock Corp. · 1983
  • K760262Radioassy Kit, 3H-FolateDiamond Shamrock Corp. · 1976

All 2 as Diamond Shamrock Corp. →

Other applicant names beginning “Diamond”

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

Diamond Diagnostics, Inc. 26Diamond Medical, Inc. 6Diamond Sensor Systems 3Diamond Medical Equipment, Inc. 3Diamond Electro-Tech, Inc. 1Diamond Orthopedic, LLC 1Diamond Rotary and Carbide Intl. 1Diamond Systems USA, Inc. 1Diamond Age Systems, Inc. 1Diamond General Development Corp. 1Diamond Orthotic Laboratory 1Diamond Mark International Co., Ltd. 1