K944605 is an FDA 510(k) clearance for the CX PHENCYCLIDINE REAGENT FOR SYNSCHRON CX SYSTEM. This device is classified as a Enzyme Immunoassay, Phencyclidine.
Submitted by Beckman-Diagnostic Systems Group (Brea, US). The FDA issued a Cleared decision on December 7, 1994, 79 days after receiving the submission on September 19, 1994.
This device falls under the Toxicology FDA review panel.
| 510(k) Number | K944605 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 19, 1994 |
| Decision Date | December 07, 1994 |
| Days to Decision | 79 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | LCM — Enzyme Immunoassay, Phencyclidine |
| Device Class | — |