FDA applicant

Sigma Chemical Co.

St. Louis, MO231 decisions1976–19940 recalls

FDA records 231 decisions for Sigma Chemical Co. (St. Louis, MO) from 1976 to 1994: 231 510(k) clearances. Most are in product codes KIT (Media And Components, Synthetic Cell And…) and GGP (Test, Qualitative And Quantitative 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, hematology panel, where it files most

How often FDA has decided Sigma Chemical Co.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sigma Chemical Co. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Sigma Chemical Co. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Sigma”

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

Sigma Diagnostics, Inc. 164 Sigma Medical, Inc. 13 Sigma 6 Sigma Medical Supplies Corp. 5 Sigma Intl. 3 Sigma Cell Culture Reagents 2 Sigma Scientific Services, LLC 1 Sigma Teleproducts, Inc. 1 Sigma Biomedics, Inc. 1 Sigma Vision, Inc. 1 Sigma Intl. General Medical Apparatus, Inc. 1 Sigma-Brillen 1

Sigma Chemical Co.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Sigma”