K872426 is an FDA 510(k) clearance for the CYTOTECH C1-INHIBITOR ENZYME IMMUNOASSAY. This device is classified as a Complement C1 Inhibitor (inactivator), Antigen, Antiserum, Control (Class II - Special Controls, product code DBA).
Submitted by Cytotech, Inc. (San Diego, US). The FDA issued a Cleared decision on July 23, 1987, 31 days after receiving the submission on June 22, 1987.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5250.
| 510(k) Number | K872426 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 22, 1987 |
| Decision Date | July 23, 1987 |
| Days to Decision | 31 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | DBA — Complement C1 Inhibitor (inactivator), Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5250 |