K010047 is an FDA 510(k) clearance for the INSTANT-VIEW PHENCYCLIDINE (PCP) URINE CASSETTE TEST. This device is classified as a Enzyme Immunoassay, Phencyclidine.
Submitted by Alfa Scientific Designs, Inc. (Poway, US). The FDA issued a Cleared decision on May 29, 2001, 144 days after receiving the submission on January 5, 2001.
This device falls under the Toxicology FDA review panel.
| 510(k) Number | K010047 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 05, 2001 |
| Decision Date | May 29, 2001 |
| Days to Decision | 144 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | LCM — Enzyme Immunoassay, Phencyclidine |
| Device Class | — |