FDA applicant

Granite Diagnostics, Inc.

Mchenry, IL47 decisions1977–19850 recalls

FDA records 47 decisions for Granite Diagnostics, Inc. (Mchenry, IL) from 1977 to 1985: 47 510(k) clearances. Most are in product codes JSJ (Culture Media, Selective And Non-Differential) and JSI (Culture Media, Selective And Differential). 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, microbiology panel, where it files most

How often FDA has decided Granite Diagnostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Granite Diagnostics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Granite Diagnostics, 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 “Granite”

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

Granite Chemical Co., Inc. 3

Granite Diagnostics, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Granite”