Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cytotech, Inc. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
55 daysmedian FDA review time
137 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K882829 | CIRCULATING IMMUNE COMPLEXES CONTROLS | Cytotech, Inc. | 1988-08-04 | 27 | 0 |
| K874379 | CIC-RAJI CELL REPLACEMENT ENZYME IMMUNOASSAY | Cytotech, Inc. | 1987-11-25 | 30 | 0 |
| K873249 | ANTINUCLEAR ANTIBODY (ANA) POSITIVE CONTROLS | Cytotech, Inc. | 1987-09-22 | 36 | 0 |
| K872426 | CYTOTECH C1-INHIBITOR ENZYME IMMUNOASSAY | Cytotech, Inc. | 1987-07-23 | 31 | 1 |
| K871801 | CYTOTECH ANTINUCLEAR ANTIBODY (ANA) IFA KIT | Cytotech, Inc. | 1987-06-09 | 32 | 0 |
| K864315 | CYTOTECH RUBELLA IGG ENZYME IMMUNOASSAY | Cytotech, Inc. | 1987-02-02 | 91 | 0 |
| K862838 | CYTOTECH HSV IGG ENZYME IMMUNOASSAY | Cytotech, Inc. | 1986-12-09 | 137 | 0 |
| K863363 | CYTOTECH TOXOPLASMA IGG ENZYME IMMUNOASSAY | Cytotech, Inc. | 1986-11-13 | 72 | 0 |
| K862649 | CYTOTECH CIC ENZYME IMMUNOASSAY | Cytotech, Inc. | 1986-09-04 | 55 | 0 |
| K860493 | CYTOTECH CMV IGG EIA | Cytotech, Inc. | 1986-05-20 | 99 | 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