Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Infrared Laboratory Systems, LLC (Dba Synermed) · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K181201 | Synermed ISE Reagents | Infrared Laboratory Systems, LLC (Dba Synermed) | 2018-07-10 | 64 | 0 |
| K172416 | Synermed Opiate Enzyme Immunoassay | Infrared Laboratory Systems, LLC (Dba Synermed) | 2018-04-19 | 252 | 0 |
| K153692 | Synermed Glucose Reagent, Synermed IR-1200 Chemistry Analyze | Infrared Laboratory Systems, LLC (Dba Synermed) | 2016-06-24 | 184 | 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