Cytotech, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Cytotech, Inc.” (first 1986, latest 1988), across 9 product codes in 3 review panels. Median 510(k) review time under this name: 46 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DAK | Complement C1q, Antigen, Antiserum, Control | 2 | 2 |
| CZY | Complement C1s, Antigen, Antiserum, Control | 1 | 1 |
| DBA | Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control | 1 | 1 |
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 1 | 1 |
| GCO | Endoscope, Mirror | 1 | 1 |
| GQI | Antiserum, Cf, Cytomegalovirus | 1 | 1 |
| LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 1 | 1 |
| LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | 1 | 1 |
| LKJ | Antinuclear Antibody, Antigen, Control | 1 | 1 |
Review panels
Most recent Cytotech, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K882829 | CIRCULATING IMMUNE COMPLEXES CONTROLS | DAK | 1988-08-04 | 27 |
| K874379 | CIC-RAJI CELL REPLACEMENT ENZYME IMMUNOASSAY | CZY | 1987-11-25 | 30 |
| K873249 | ANTINUCLEAR ANTIBODY (ANA) POSITIVE CONTROLS | LKJ | 1987-09-22 | 36 |
| K872426 | CYTOTECH C1-INHIBITOR ENZYME IMMUNOASSAY | DBA | 1987-07-23 | 31 |
| K871801 | CYTOTECH ANTINUCLEAR ANTIBODY (ANA) IFA KIT | DHN | 1987-06-09 | 32 |
| K864315 | CYTOTECH RUBELLA IGG ENZYME IMMUNOASSAY | LFX | 1987-02-02 | 91 |
| K862838 | CYTOTECH HSV IGG ENZYME IMMUNOASSAY | GCO | 1986-12-09 | 137 |
| K863363 | CYTOTECH TOXOPLASMA IGG ENZYME IMMUNOASSAY | LGD | 1986-11-13 | 72 |
| K862649 | CYTOTECH CIC ENZYME IMMUNOASSAY | DAK | 1986-09-04 | 55 |
| K860493 | CYTOTECH CMV IGG EIA | GQI | 1986-05-20 | 99 |
Recalls
openFDA lists no recalls under a recalling firm named Cytotech, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Cytotech, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Cytotech, Inc.” (first 1986, latest 1988), across 9 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Cytotech, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cytotech, Inc. is 46 days.
Which FDA product codes appear under Cytotech, Inc.?
The most frequent FDA product codes under this applicant name are DAK (Complement C1q, Antigen, Antiserum, Control, 2); CZY (Complement C1s, Antigen, Antiserum, Control, 1); DBA (Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control, 1).
Next steps
- See all 10 Cytotech, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DAK, Cytotech, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.