Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Diagnostica Stago, Inc. · Predicate Candidate Screening
16 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
122 daysmedian FDA review time
312 days90th percentile
16clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253658 | STA Satellite Max® | Diagnostica Stago, Inc. | 2026-04-27 | 158 | 0 |
| K120014 | STA- COAG CONTROL (N+ABN) PLUS | Diagnostica Stago, Inc. | 2013-03-14 | 441 | 0 |
| K111822 | STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / | Diagnostica Stago, Inc. | 2011-10-26 | 120 | 3 |
| K092937 | STA-HYBRID HEP CALIBRATOR | Diagnostica Stago, Inc. | 2010-08-02 | 312 | 0 |
| K093167 | STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER | Diagnostica Stago, Inc. | 2009-12-22 | 76 | 1 |
| K092170 | STA LIATEST FREE PS | Diagnostica Stago, Inc. | 2009-12-22 | 154 | 0 |
| K092113 | STA - FREE PS CALIBRATOR | Diagnostica Stago, Inc. | 2009-11-13 | 122 | 0 |
| K082248 | STA SATELLITE AUTOMATED MULTI-PARAMETER ANALYZER | Diagnostica Stago, Inc. | 2008-12-12 | 126 | 2 |
| K082675 | STA-R EVOLUTION AUTOMATED MULTI-PARAMETRIC ANALYZER | Diagnostica Stago, Inc. | 2008-10-10 | 25 | 0 |
| K061805 | STA - STACLOT DRVV SCREEN; STA - STACLOT DRVV CONFIRM | Diagnostica Stago, Inc. | 2006-12-06 | 162 | 0 |
| K061803 | STA - CONTROL LA 1+2 | Diagnostica Stago, Inc. | 2006-07-28 | 31 | 0 |
| K053111 | STA-CEPHASCREEN KIT | Diagnostica Stago, Inc. | 2006-05-04 | 181 | 0 |
| K010963 | STA-LIATEST FREE PROTEIN S TEST KIT | Diagnostica Stago, Inc. | 2001-06-06 | 68 | 1 |
| K010350 | STA -CALIBRATOR HBPM/LMWH KIT | Diagnostica Stago, Inc. | 2001-04-09 | 63 | 0 |
| K010324 | STA-QUALITY HBPM/LMWH KIT | Diagnostica Stago, Inc. | 2001-04-09 | 66 | 0 |
| K003767 | ASSERACHROM HPIA TEST KIT | Diagnostica Stago, Inc. | 2001-02-12 | 68 | 1 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda