K010358 is an FDA 510(k) clearance for the VIGIL SEROLOGY CONTROL LEVEL C. This device is classified as a Multi-analyte Controls, All Kinds (assayed) (Class I - General Controls, product code JJY).
Submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on March 5, 2001, 27 days after receiving the submission on February 6, 2001.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 862.1660.
| 510(k) Number | K010358 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 06, 2001 |
| Decision Date | March 05, 2001 |
| Days to Decision | 27 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | JJY — Multi-analyte Controls, All Kinds (assayed) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1660 |