K890688 is an FDA 510(k) clearance for the ADX TM PHENCYCLIDINE. This device is classified as a Enzyme Immunoassay, Phencyclidine.
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on August 25, 1989, 192 days after receiving the submission on February 14, 1989.
This device falls under the Toxicology FDA review panel.
| 510(k) Number | K890688 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 14, 1989 |
| Decision Date | August 25, 1989 |
| Days to Decision | 192 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | LCM — Enzyme Immunoassay, Phencyclidine |
| Device Class | — |