K011730 is an FDA 510(k) clearance for the ACON PCP ONE-STEP PHENCYCLIDINE TEST STRIP, ACON PCP ONE-STEP PHENCYCLIDINE TEST DEVICE. This device is classified as a Enzyme Immunoassay, Phencyclidine.
Submitted by ACON Laboratories, Inc. (San Diego, US). The FDA issued a Cleared decision on August 9, 2001, 65 days after receiving the submission on June 5, 2001.
This device falls under the Toxicology FDA review panel.
| 510(k) Number | K011730 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 05, 2001 |
| Decision Date | August 09, 2001 |
| Days to Decision | 65 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | LCM — Enzyme Immunoassay, Phencyclidine |
| Device Class | — |