Company ยท US
Cytotech, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1986 to 1988. Name variants (Inc, Corp, punctuation) are merged.
10510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DAK | Complement C1q, Antigen, Antiserum, Control | 2 |
| CZY | Complement C1s, Antigen, Antiserum, Control | 1 |
| DBA | Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control | 1 |
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 1 |
| GCO | Endoscope, Mirror | 1 |
| GQI | Antiserum, Cf, Cytomegalovirus | 1 |
| LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 1 |
| LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | 1 |
| LKJ | Antinuclear Antibody, Antigen, Control | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 4, 1988 | K882829 | CIRCULATING IMMUNE COMPLEXES CONTROLS Cytotech, Inc. | DAK |
| Nov 25, 1987 | K874379 | CIC-RAJI CELL REPLACEMENT ENZYME IMMUNOASSAY Cytotech, Inc. | CZY |
| Sep 22, 1987 | K873249 | ANTINUCLEAR ANTIBODY (ANA) POSITIVE CONTROLS Cytotech, Inc. | LKJ |
| Jul 23, 1987 | K872426 | CYTOTECH C1-INHIBITOR ENZYME IMMUNOASSAY Cytotech, Inc. | DBA |
| Jun 9, 1987 | K871801 | CYTOTECH ANTINUCLEAR ANTIBODY (ANA) IFA KIT Cytotech, Inc. | DHN |
| Feb 2, 1987 | K864315 | CYTOTECH RUBELLA IGG ENZYME IMMUNOASSAY Cytotech, Inc. | LFX |
| Dec 9, 1986 | K862838 | CYTOTECH HSV IGG ENZYME IMMUNOASSAY Cytotech, Inc. | GCO |
| Nov 13, 1986 | K863363 | CYTOTECH TOXOPLASMA IGG ENZYME IMMUNOASSAY Cytotech, Inc. | LGD |
| Sep 4, 1986 | K862649 | CYTOTECH CIC ENZYME IMMUNOASSAY Cytotech, Inc. | DAK |
| May 20, 1986 | K860493 | CYTOTECH CMV IGG EIA Cytotech, Inc. | GQI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||