K944606 is an FDA 510(k) clearance for the CX OPIATE REAGENT FOR SYNCHRON CX SYSTEMS. This device is classified as a Enzyme Immunoassay, Opiates (Class II - Special Controls, product code DJG).
Submitted by Beckman-Diagnostic Systems Group (Brea, US). The FDA issued a Cleared decision on November 30, 1994, 72 days after receiving the submission on September 19, 1994.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3650.
| 510(k) Number | K944606 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 19, 1994 |
| Decision Date | November 30, 1994 |
| Days to Decision | 72 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | DJG — Enzyme Immunoassay, Opiates |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3650 |