K936184 is an FDA 510(k) clearance for the VIGIL PRX CHEMISTRY CONTROL. This device is classified as a Multi-analyte Controls, All Kinds (assayed) (Class I - General Controls, product code JJY).
Submitted by Beckman-Diagnostic Systems Group (Brea, US). The FDA issued a Cleared decision on April 15, 1994, 109 days after receiving the submission on December 27, 1993.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.1660.
| 510(k) Number | K936184 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 27, 1993 |
| Decision Date | April 15, 1994 |
| Days to Decision | 109 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | JJY — Multi-analyte Controls, All Kinds (assayed) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1660 |