K040925 is an FDA 510(k) clearance for the NORMAL AND HYPERGAMMA CONTROL SERUM. This device is classified as a Multi-analyte Controls, All Kinds (assayed) (Class I - General Controls, product code JJY).
Submitted by Sebia (Chelsea, US). The FDA issued a Cleared decision on April 28, 2004, 20 days after receiving the submission on April 8, 2004.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 862.1660.
| 510(k) Number | K040925 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 08, 2004 |
| Decision Date | April 28, 2004 |
| Days to Decision | 20 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | JJY — Multi-analyte Controls, All Kinds (assayed) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1660 |