FDA applicant

Primus Corp.

Kansas City, MO14 decisions1989–20071 recall

FDA records 14 decisions for Primus Corp. (Kansas City, MO) from 1989 to 2007: 14 510(k) clearances. Most are in product codes LCP (Assay, Glycosylated Hemoglobin) and DCK (C-Reactive Protein, Antigen, Antiserum, And…). Its devices cite 1 predicate, 1 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Primus, Inc.”.

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 Primus Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2020

2007high 1 (2020) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Primus Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Primus”

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

Primus Sterilizer Company, LLC 6 Primus Gloves Private, Ltd. 4 Primus Gloves Pvt Limited 3 Primus Consulting 1 Primus Corporation Dba Trinity Biotech 1

Primus Corp.

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?

What has been recalled?

Other applicant names beginning “Primus”