K862649 is an FDA 510(k) clearance for the CYTOTECH CIC ENZYME IMMUNOASSAY. This device is classified as a Complement C1q, Antigen, Antiserum, Control (Class II - Special Controls, product code DAK).
Submitted by Cytotech, Inc. (San Diego, US). The FDA issued a Cleared decision on September 4, 1986, 55 days after receiving the submission on July 11, 1986.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5240.
| 510(k) Number | K862649 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 11, 1986 |
| Decision Date | September 04, 1986 |
| Days to Decision | 55 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | DAK — Complement C1q, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5240 |