Meridian Diagnostics, Inc.: FDA clearances and approvals
Meridian Diagnostics, Inc. has 92 FDA 510(k) clearances (first 1980, latest 1999), across 54 product codes in 6 review panels. Median 510(k) review time: 33 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 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 |
|---|---|---|---|
| LLH | Reagents, Clostridium Difficile Toxin | 6 | 6 |
| LYR | Helicobacter Pylori | 5 | 5 |
| GMI | Antigen, Cf And / Or Id, Coccidioides Immitis | 4 | 4 |
| GMJ | Antigens, Histoplasma Capsulatum, All | 4 | 4 |
| GMK | Antiserum, Positive Control, Histoplasma Capsulatum | 4 | 4 |
| GMH | Antiserum, Positive Control, Coccidioides Immitis | 3 | 3 |
| IGG | Formaldehyde (Formalin, Formol) | 3 | 3 |
| KEQ | Media, Mounting, Water Soluble | 3 | 3 |
| LIQ | Enzyme Linked Immunoabsorbent Assay, Rotavirus | 3 | 3 |
| DHR | System, Test, Rheumatoid Factor | 2 | 2 |
Plus 44 more product codes.
Review panels
- Microbiology (75)
- Pathology (10)
- Immunology (3)
- Clinical Chemistry (1)
- General Hospital (1)
- Orthopedic (1)
Most recent Meridian Diagnostics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K993914 | PREMIER TOXINS A&B, MODEL 616096 | LLH | 1999-12-10 | 23 |
| K990263 | IMMUNOCARD STAT! E. COLI O157:H7 | GMZ | 1999-08-09 | 194 |
| K984346 | PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TEST | LGC | 1999-06-25 | 203 |
| K984343 | PREMIER TYPE SPECIFIC HSV-1 IGG ELISA TEST | MXJ | 1999-06-25 | 203 |
| K983255 | MODIFICATION TO: PREMIER PLATINUM HPSA | LYR | 1998-12-17 | 93 |
| K982764 | PREMIER CRYPTOSPORIDIUM | MHJ | 1998-12-03 | 119 |
| K982711 | PREMIER GIARDIA | MHI | 1998-11-25 | 113 |
| K980076 | PREMIER PLATINUM HPSA | LYR | 1998-05-12 | 124 |
| K980077 | PARA-PAK SPINCON | LKS | 1998-04-02 | 84 |
| K971585 | IMMUNOCARD STAT! ROTAVIRUS | LIQ | 1997-08-20 | 111 |
82 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Meridian Diagnostics, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Meridian Diagnostics, Inc. have?
Meridian Diagnostics, Inc. has 92 FDA 510(k) clearances (first 1980, latest 1999), across 54 product codes in 6 review panels.
How long does FDA take to clear Meridian Diagnostics, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Meridian Diagnostics, Inc.'s cleared 510(k)s is 33 days.
What devices does Meridian Diagnostics, Inc. make?
Its most frequent FDA product codes are LLH (Reagents, Clostridium Difficile Toxin, 6); LYR (Helicobacter Pylori, 5); GMI (Antigen, Cf And / Or Id, Coccidioides Immitis, 4).
Has Meridian Diagnostics, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Meridian Diagnostics, Inc. Related entities may recall under other names.
Next steps
- See all 92 Meridian Diagnostics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LLH, Meridian Diagnostics, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.