Modern Diagnostics, Inc.: FDA clearances and approvals
Modern Diagnostics, Inc. has 5 FDA 510(k) clearances (first 1985, latest 1985), across 4 product codes in 2 review panels. Median 510(k) review time: 50 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 |
|---|---|---|---|
| JHI | Visual, Pregnancy Hcg, Prescription Use | 2 | 2 |
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 1 | 1 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 1 | 1 |
| LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | 1 | 1 |
Review panels
- Clinical Chemistry (3)
- Immunology (2)
Most recent Modern Diagnostics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K853269 | PREGNA/TEST | LCX | 1985-10-03 | 59 |
| K853258 | BETA-HCG MICROTITER PREGNANCY TEST | JHI | 1985-10-01 | 60 |
| K853006 | HUMAN CHORIONIC GONAD TEST SYS FOR EARLY PREGNANCY | JHI | 1985-09-04 | 50 |
| K852840 | ENZYME ANTINUCLEAR ANTIBODY SCREENING TEST | LJM | 1985-08-01 | 27 |
| K851369 | ANTINUCLEAR ANTIBODY TEST KIT | DHN | 1985-05-15 | 40 |
Recalls
openFDA lists no recalls under a recalling firm named Modern 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 Modern Diagnostics, Inc. have?
Modern Diagnostics, Inc. has 5 FDA 510(k) clearances (first 1985, latest 1985), across 4 product codes in 2 review panels.
How long does FDA take to clear Modern Diagnostics, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Modern Diagnostics, Inc.'s cleared 510(k)s is 50 days.
What devices does Modern Diagnostics, Inc. make?
Its most frequent FDA product codes are JHI (Visual, Pregnancy Hcg, Prescription Use, 2); DHN (Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control, 1); LCX (Kit, Test, Pregnancy, Hcg, Over The Counter, 1).
Has Modern Diagnostics, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Modern Diagnostics, Inc. Related entities may recall under other names.
Next steps
- See all 5 Modern Diagnostics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JHI, Modern 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.