Cd Diagnostics, Inc.: FDA clearances and approvals
Cd Diagnostics, Inc. has 1 FDA 510(k) clearance (first 2021, latest 2021), plus 1 De Novo decision, across 1 product code in 1 review panel. Median 510(k) review time: 27 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2021 | 1 | 27 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Cd Diagnostics, Inc.'s cleared 510(k)s took a median 27 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 27 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QGN | Lateral Flow Immunochromatography Assay For Host Infection Biomarkers | 2 | 1 |
Review panels
- Microbiology (2)
Most recent Cd Diagnostics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K212204 | Synovasure Alpha Defensin Lateral Flow Test Kit (1 Kit), Synovasure Alpha Defensin Lateral Flow Test Kit (5 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (10 Test), Synovasure Alpha Defensin Flow Test Kit (30 Test), Synovasure Alpha Defensin Control Kit | QGN | 2021-08-11 | 27 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN180032 | De Novo | Lateral Flow Immunochromatography Assay For Host Infection Biomarkers | 2019-05-23 |
Recalls
openFDA lists no recalls under a recalling firm named Cd 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 Cd Diagnostics, Inc. have?
Cd Diagnostics, Inc. has 1 FDA 510(k) clearance (first 2021, latest 2021), plus 1 De Novo decision, across 1 product code in 1 review panel.
How long does FDA take to clear Cd Diagnostics, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Cd Diagnostics, Inc.'s cleared 510(k)s is 27 days.
What devices does Cd Diagnostics, Inc. make?
Its most frequent FDA product codes are QGN (Lateral Flow Immunochromatography Assay For Host Infection Biomarkers, 2).
Has Cd Diagnostics, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Cd Diagnostics, Inc. Related entities may recall under other names.
Next steps
- See all 1 Cd Diagnostics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code QGN, Cd 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.