FDA applicant

Genetic Laboratories, Inc.

St. Paul, MN4 decisions1982–19850 recalls

FDA records 4 decisions for Genetic Laboratories, Inc. (St. Paul, MN) from 1982 to 1985: 3 510(k) clearances and 1 original PMA approval. Most are in product codes DXZ (Patch, Pledget And Intracardiac, Petp, Ptfe…) and MCI (Graft, Vascular, Hemodialysis Access…). 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 Genetic Laboratories, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Genetic Laboratories, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Genetic Laboratories, Inc.’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 “Genetic”

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

Genetic Systems Corp. 12 Genetic Testing Institute 6 Genetic Signatures Limited 1 Genetic 1 Genetic Laboratories Wound Care, Inc. 1

Genetic Laboratories, Inc.

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 “Genetic”