Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
California Integrated Diagnostics, Inc. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K904095 | HERPES SIMPLEX VIRUS TISSUE CULTURE CONF. TYPING | California Integrated Diagnostics, Inc. | 1991-02-01 | 148 | 0 |
| K874259 | TRICHOMONAS DIRECT ENZYME IMMUNOASSAY | California Integrated Diagnostics, Inc. | 1987-12-07 | 48 | 0 |
| K871279 | MODIFIED TRICHOMONAS DIRECT SPECIMEN TEST KIT | California Integrated Diagnostics, Inc. | 1987-04-08 | 8 | 0 |
| K871278 | MODIFIED CHLAMYDIA DIRECT SPECIMEN TEST KIT | California Integrated Diagnostics, Inc. | 1987-04-08 | 8 | 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