Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
CJO · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K122323 | DIMENSION VISTA ALKALINE PHOSPHATASE (ALPI) FLEX REAGENT CAR | Siemens Healthcare Diagnostics | 2012-08-28 | 27 | 1 |
| K121907 | DIMENSION ALKALINE PHOSPHATASE FLEX REAGENT CARTRIDGE, DIMEN | Siemens Healthcare Diagnostics | 2012-07-23 | 24 | 0 |
| K982328 | BAYER ADVIA IMS SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) | Bayer Corp. | 1999-01-29 | 211 | 0 |
| K770155 | ALKALINE PHOSPHATASE ISOYZME REAGENT SET | Gelman Instrument Co. | 1977-01-31 | 7 | 0 |
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