American Dade: FDA clearances and approvals
American Dade has 149 FDA 510(k) clearances (first 1980, latest 1987), across 95 product codes in 6 review panels. Median 510(k) review time: 42 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 |
|---|---|---|---|
| GGP | Test, Qualitative And Quantitative Factor Deficiency | 9 | 9 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 9 | 9 |
| GIO | Tube, Collection, Capillary Blood | 5 | 5 |
| JPK | Mixture, Hematology Quality Control | 5 | 5 |
| JIT | Calibrator, Secondary | 4 | 4 |
| JIX | Calibrator, Multi-Analyte Mixture | 4 | 4 |
| CIG | Diazo Colorimetry, Bilirubin | 3 | 3 |
| GJS | Test, Time, Prothrombin | 3 | 3 |
| JJS | Controls For Blood-Gases, (Assayed And Unassayed) | 3 | 3 |
| JQW | Station, Pipetting And Diluting, For Clinical Use | 3 | 3 |
Plus 85 more product codes.
Review panels
- Clinical Chemistry (77)
- Hematology (44)
- Clinical Toxicology (21)
- Microbiology (4)
- Immunology (2)
- Pathology (1)
Most recent American Dade 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K873051 | STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAY | CGJ | 1987-10-20 | 77 |
| K873171 | STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY | JHX | 1987-09-29 | 49 |
| K873052 | STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAY | CEP | 1987-09-14 | 41 |
| K872789 | PARAMAX URINE/CSF CALIBRATOR | JIX | 1987-09-02 | 50 |
| K872195 | DATA-FI DIMERTEST LATEX ASSAY | DAP | 1987-08-06 | 59 |
| K872196 | AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III | JJS | 1987-07-31 | 53 |
| K871972 | STRATUS IGE FLUOROMETRIC ENZYME IMMUNOASSAY | DGE | 1987-07-21 | 61 |
| K871977 | DADE MONI-TROL CHEMISTRY CONTROL/CALIBRATOR | JJY | 1987-07-09 | 48 |
| K872050 | PARAMAX CHOLESTEROL REAGENT | LBS | 1987-07-07 | 40 |
| K872360 | DATA-FI FIBRIN(OGEN) DEGRADATION PROD.(FDP)DET SET | GHH | 1987-07-06 | 18 |
139 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named American Dade.
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of American Dade's product codes (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances does American Dade have?
American Dade has 149 FDA 510(k) clearances (first 1980, latest 1987), across 95 product codes in 6 review panels.
How long does FDA take to clear American Dade's 510(k)s?
The median time from FDA receipt to decision across American Dade's cleared 510(k)s is 42 days.
What devices does American Dade make?
Its most frequent FDA product codes are GGP (Test, Qualitative And Quantitative Factor Deficiency, 9); JJY (Multi-Analyte Controls, All Kinds (Assayed), 9); GIO (Tube, Collection, Capillary Blood, 5).
Has American Dade had device recalls?
openFDA lists no recalls under a recalling firm name matching American Dade. Related entities may recall under other names.
Next steps
- See all 149 American Dade clearances with predicates and recalls
- Run predicate analysis for product code GGP, American Dade'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.