K854819 is an FDA 510(k) clearance for the CPR SLIDE EIKEN. This device is classified as a System, Test, C-reactive Protein (Class II - Special Controls, product code DCN).
Submitted by Syn-Kit, Inc. (Chatsworth, US). The FDA issued a Cleared decision on February 26, 1986, 85 days after receiving the submission on December 3, 1985.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5270.
| 510(k) Number | K854819 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 03, 1985 |
| Decision Date | February 26, 1986 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | DCN — System, Test, C-reactive Protein |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5270 |