K900940 is an FDA 510(k) clearance for the TDX PHENCYCLIDINE II ASSAY. This device is classified as a Enzyme Immunoassay, Phencyclidine.
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on April 25, 1990, 56 days after receiving the submission on February 28, 1990.
This device falls under the Toxicology FDA review panel.
| 510(k) Number | K900940 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 28, 1990 |
| Decision Date | April 25, 1990 |
| Days to Decision | 56 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | LCM — Enzyme Immunoassay, Phencyclidine |
| Device Class | — |