K854167 is an FDA 510(k) clearance for the TDX PHENCYCLIDINE. This device is classified as a Enzyme Immunoassay, Phencyclidine.
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on November 5, 1985, 21 days after receiving the submission on October 15, 1985.
This device falls under the Chemistry FDA review panel.
| 510(k) Number | K854167 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 15, 1985 |
| Decision Date | November 05, 1985 |
| Days to Decision | 21 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | LCM — Enzyme Immunoassay, Phencyclidine |
| Device Class | — |