K874379 is an FDA 510(k) clearance for the CIC-RAJI CELL REPLACEMENT ENZYME IMMUNOASSAY. This device is classified as a Complement C1s, Antigen, Antiserum, Control (Class II - Special Controls, product code CZY).
Submitted by Cytotech, Inc. (San Diego, US). The FDA issued a Cleared decision on November 25, 1987, 30 days after receiving the submission on October 26, 1987.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5240.
| 510(k) Number | K874379 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 26, 1987 |
| Decision Date | November 25, 1987 |
| Days to Decision | 30 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | CZY — Complement C1s, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5240 |