Diagnostica Stago, Inc.: FDA clearances and approvals
Diagnostica Stago, Inc. has 18 FDA 510(k) clearances (first 2001, latest 2026), across 11 product codes in 2 review panels. Median 510(k) review time: 123 days. openFDA lists 42 product recalls by a recalling firm named Diagnostica Stago, Inc. It is the industry lead sponsor of 2 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 441 |
| 2014 | 1 | 124 |
| 2015 | 0 | — |
| 2016 | 1 | 124 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 1 | 158 |
Review time against the same product codes
Since 2017, Diagnostica Stago, Inc.'s cleared 510(k)s took a median 158 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 96 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JPA | System, Multipurpose For In Vitro Coagulation Studies | 4 | 4 |
| GGN | Plasma, Coagulation Control | 3 | 3 |
| DAP | Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control | 2 | 2 |
| GGP | Test, Qualitative And Quantitative Factor Deficiency | 2 | 2 |
| GFO | Activated Partial Thromboplastin | 1 | 1 |
| GGC | Control, Plasma, Abnormal | 1 | 1 |
| GIR | Reagent, Russel Viper Venom | 1 | 1 |
| JIT | Calibrator, Secondary | 1 | 1 |
| JIX | Calibrator, Multi-Analyte Mixture | 1 | 1 |
| KFF | Assay, Heparin | 1 | 1 |
Plus 1 more product codes.
Review panels
- Hematology (16)
- Clinical Chemistry (2)
Most recent Diagnostica Stago, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253658 | STA Satellite Max® | JPA | 2026-04-27 | 158 |
| K162227 | STA® - Liatest® D-Di | DAP | 2016-12-10 | 124 |
| K141144 | STA LIATEST D-DI | DAP | 2014-09-03 | 124 |
| K120014 | STA- COAG CONTROL (N+ABN) PLUS | GGN | 2013-03-14 | 441 |
| K111822 | STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWH | KFF | 2011-10-26 | 120 |
| K092937 | STA-HYBRID HEP CALIBRATOR | JIT | 2010-08-02 | 312 |
| K093167 | STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER | JPA | 2009-12-22 | 76 |
| K092170 | STA LIATEST FREE PS | GGP | 2009-12-22 | 154 |
| K092113 | STA - FREE PS CALIBRATOR | JIX | 2009-11-13 | 122 |
| K082248 | STA SATELLITE AUTOMATED MULTI-PARAMETER ANALYZER | JPA | 2008-12-12 | 126 |
8 earlier clearances. See the full list in Caduvo.
Recalls
42 product recalls in 30 recall events; 13 initiated in the last five years. Most recent: 2026-07-29.
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.
Device clinical trials
Diagnostica Stago, Inc. is the industry lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT03073265: Apixaban Validation Study - Additional Study on Fresh Samples (Completed, started 2017-05-08)
- NCT02333929: Validation of Rivaroxaban Assay for US Registration (Completed, started 2015-03)
Frequently asked questions
How many FDA 510(k) clearances does Diagnostica Stago, Inc. have?
Diagnostica Stago, Inc. has 18 FDA 510(k) clearances (first 2001, latest 2026), across 11 product codes in 2 review panels.
How long does FDA take to clear Diagnostica Stago, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Diagnostica Stago, Inc.'s cleared 510(k)s is 123 days.
What devices does Diagnostica Stago, Inc. make?
Its most frequent FDA product codes are JPA (System, Multipurpose For In Vitro Coagulation Studies, 4); GGN (Plasma, Coagulation Control, 3); DAP (Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control, 2).
Has Diagnostica Stago, Inc. had device recalls?
openFDA lists 42 product recalls in 30 recall events by a recalling firm whose name matches Diagnostica Stago, Inc; the most recent began 2026-07-29. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 18 Diagnostica Stago, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JPA, Diagnostica Stago, 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.