K043071 is an FDA 510(k) clearance for the RANDOX PHENCYCLIDINE ASSAY. This device is classified as a Enzyme Immunoassay, Phencyclidine.
Submitted by Randox Laboratories, Ltd. (Crumlin, GB). The FDA issued a Cleared decision on January 27, 2005, 80 days after receiving the submission on November 8, 2004.
This device falls under the Chemistry FDA review panel.
| 510(k) Number | K043071 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 08, 2004 |
| Decision Date | January 27, 2005 |
| Days to Decision | 80 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | LCM — Enzyme Immunoassay, Phencyclidine |
| Device Class | — |