Dade Intl., Inc.: FDA clearances and approvals
Dade Intl., Inc. has 30 FDA 510(k) clearances (first 1995, latest 1998), plus 1 PMA decision, across 27 product codes in 5 review panels. Median 510(k) review time: 63 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 |
|---|---|---|---|
| JIT | Calibrator, Secondary | 2 | 2 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 2 | 2 |
| JWY | Manual Antimicrobial Susceptibility Test Systems | 2 | 2 |
| MMI | Immunoassay Method, Troponin Subunit | 2 | 2 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 1 | 1 |
| CEC | Radioimmunoassay, Free Thyroxine | 1 | 1 |
| CEM | Electrode, Ion Specific, Potassium | 1 | 1 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 | 1 |
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | 1 | 1 |
| DDR | Myoglobin, Antigen, Antiserum, Control | 1 | 1 |
Plus 17 more product codes.
Review panels
- Clinical Chemistry (16)
- Clinical Toxicology (7)
- Microbiology (4)
- Hematology (3)
- Immunology (1)
Most recent Dade Intl., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K974343 | DADE INNOVIN | GJS | 1998-07-22 | 245 |
| K970505 | DADE PFA-100 PLATELET FUNCTION ANALYZER/PFA COLLAGEN/EPINEPHRINE TEST CARTRIDGE/PFA COLLAGEN/ADP TEST CARTRIDGE/ | JOZ | 1997-11-17 | 280 |
| K973974 | DADE TRU-LIQUID CARDIAC CONTROL | JJT | 1997-11-06 | 17 |
| K973668 | CARDIAC TROPONIN-I (TROP) CALIBRATOR | JIT | 1997-10-20 | 25 |
| K972524 | DRIED GRAM-POSITIVE MIC/COMBO PANELS | JWY | 1997-09-08 | 63 |
| K972782 | DADE STRATUS CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY | JHX | 1997-08-15 | 21 |
| K972287 | DADE TRU-LIQUID BILIRUBIN CONTROL | JJX | 1997-07-07 | 18 |
| K964660 | PARAMAX CHOLESTEROL REAGENT | CHH | 1997-06-04 | 196 |
| K970676 | DRIED GRAM-NEGATIVE MIC/COMBO PANELS | JWY | 1997-05-02 | 67 |
| K964715 | PARAMAX SALICYLATE REAGENT | DKJ | 1997-04-25 | 151 |
20 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P870049 | PMA | MICROSCAN RAPID PANELS | 1988-02-24 |
Recalls
openFDA lists no recalls under a recalling firm named Dade Intl., 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 Dade Intl., Inc. have?
Dade Intl., Inc. has 30 FDA 510(k) clearances (first 1995, latest 1998), plus 1 PMA decision, across 27 product codes in 5 review panels.
How long does FDA take to clear Dade Intl., Inc.'s 510(k)s?
The median time from FDA receipt to decision across Dade Intl., Inc.'s cleared 510(k)s is 63 days.
What devices does Dade Intl., Inc. make?
Its most frequent FDA product codes are JIT (Calibrator, Secondary, 2); JJX (Single (Specified) Analyte Controls (Assayed And Unassayed), 2); JWY (Manual Antimicrobial Susceptibility Test Systems, 2).
Has Dade Intl., Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Dade Intl., Inc. Related entities may recall under other names.
Next steps
- See all 30 Dade Intl., Inc. clearances with predicates and recalls
- Run predicate analysis for product code JIT, Dade Intl., 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.