Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Clinical Diagnostic Solutions, Inc. · 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) |
|---|---|---|---|---|---|
| K041130 | CDS HEMATOLOGY CALIBRATOR (CDS CAL) | Clinical Diagnostic Solutions, Inc. | 2004-06-10 | 41 | 0 |
| K024173 | CDS 3-PD HEMATOLOGY CONTROLS | Clinical Diagnostic Solutions, Inc. | 2003-01-14 | 27 | 7 |
| K993375 | CDS LTX CONTROL LATEX PARTICLE SUSPENSION AND PRIMER | Clinical Diagnostic Solutions, Inc. | 1999-12-20 | 74 | 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