K020254 is an FDA 510(k) clearance for the PHENCYCLIDINE ENZYME IMMUNOASSAY, CATALOG NUMBERS 0010 & 0011. This device is classified as a Enzyme Immunoassay, Phencyclidine.
Submitted by Lin-Zhi International, Inc. (San Jose, US). The FDA issued a Cleared decision on May 10, 2002, 106 days after receiving the submission on January 24, 2002.
This device falls under the Toxicology FDA review panel.
| 510(k) Number | K020254 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 24, 2002 |
| Decision Date | May 10, 2002 |
| Days to Decision | 106 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | LCM — Enzyme Immunoassay, Phencyclidine |
| Device Class | — |