Immuno-Mycologics, Inc.: FDA filings under this applicant name
FDA lists 26 510(k) clearances under the applicant name “Immuno-Mycologics, Inc.” (first 1979, latest 2012), across 17 product codes in 1 review panel. Median 510(k) review time under this name: 36 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 240 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GMD | Antisera, Latex Agglutination, Cryptococcus Neoformans | 4 | 4 |
| GMJ | Antigens, Histoplasma Capsulatum, All | 4 | 4 |
| GMK | Antiserum, Positive Control, Histoplasma Capsulatum | 3 | 3 |
| GMI | Antigen, Cf And / Or Id, Coccidioides Immitis | 2 | 2 |
| GMA | Antisera, Fluorescent, Sporothrix Schenekii | 1 | 1 |
| GMG | Antigen, Latex Agglutination, Coccidioides Immitis | 1 | 1 |
| GMH | Antiserum, Positive Control, Coccidioides Immitis | 1 | 1 |
| GSN | Antiserum, Positive And Negative Febrile Antigen Control Serum | 1 | 1 |
| JTL | Plasma, Coagulase, Human, Horse And Rabbit | 1 | 1 |
| JWT | Antigen, Cf, Aspergillus Spp. | 1 | 1 |
Plus 7 more product codes.
Review panels
- Microbiology (26)
Most recent Immuno-Mycologics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K120946 | ALPHA CRYPTOCOCCAL ANTIGEN EIA | MDU | 2012-12-17 | 263 |
| K112422 | CRAG LATERAL FLOW ASSAY (LFA) | GMD | 2012-03-28 | 218 |
| K102286 | CRAG LATERAL FLOW ASSAY (CRAG LFA) | GMD | 2011-07-20 | 342 |
| K101407 | ALPHA HISTOPLASMA ANTIGEN EIA MODEL HAG102 | MIZ | 2011-07-19 | 426 |
| K883333 | RABBIT PLASMA FIBRINOGEN (RPF) SUPPLEMENT | JTL | 1988-08-25 | 16 |
| K880029 | EXO-ANTIGEN IDENTIFICATION SYSTEM CAT.# EX1001 | KFH | 1988-02-24 | 50 |
| K843286 | EI-CANDIDA ENZYME IMMUNOASSAY EI1001 | LRF | 1984-10-01 | 41 |
| K831918 | LA-STAPH IDENTIFICATION SYSTEM | JWX | 1983-06-08 | 0 |
| K830837 | LA-HISTO ANTIBODY SYSTEM #HL 1001 | GMJ | 1983-05-05 | 50 |
| K810510 | YA-CRYPTO ANTIBODY TUBE AGGLUTINATION | GMD | 1981-03-20 | 24 |
16 earlier clearances. See the full list in Caduvo.
Recalls
7 product recalls in 7 recall events; 3 initiated in the last five years. Most recent: 2026-03-26.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Immuno-Mycologics, Inc.?
FDA lists 26 510(k) clearances under the applicant name “Immuno-Mycologics, Inc.” (first 1979, latest 2012), across 17 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Immuno-Mycologics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Immuno-Mycologics, Inc. is 36 days.
Which FDA product codes appear under Immuno-Mycologics, Inc.?
The most frequent FDA product codes under this applicant name are GMD (Antisera, Latex Agglutination, Cryptococcus Neoformans, 4); GMJ (Antigens, Histoplasma Capsulatum, All, 4); GMK (Antiserum, Positive Control, Histoplasma Capsulatum, 3).
Next steps
- See all 26 Immuno-Mycologics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GMD, Immuno-Mycologics, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.