FDA applicant

Immuno-Mycologics, Inc.

Mchenry, IL26 decisions1979–20125 recalls

FDA records 26 decisions for Immuno-Mycologics, Inc. (Mchenry, IL) from 1979 to 2012: 26 510(k) clearances. Most are in product codes GMD (Antisera, Latex Agglutination, Cryptococcus…) and GMJ (Antigens, Histoplasma Capsulatum, All). Its devices cite 4 predicates, 2 of them its own earlier devices. 5 recalls are 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 Immuno-Mycologics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2012

2007high 2 (2011) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2022

2007high 2 (2016) · low 0 (2007)2026

Class I Class II/III not classified

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

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

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Other applicant names beginning “Immuno-Mycologics”

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

Immuno Concepts, Inc. 36 Immuno Nuclear Corp. 30 Immuno-Products Industries 12 Immuno Assay Corp. 10 Immuno-Diagnostic Products, Inc. 8 Immuno Concepts, N.A., Ltd. 4 Immuno Diagnostic Center, Inc. 3 Immuno-Diagnostic Laboratories 2 Immuno-U.S., Inc. 1 Immuno Pathology Labs 1

Immuno-Mycologics, Inc.

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Immuno-Mycologics”