K961266 is an FDA 510(k) clearance for the ACCUSIGN, BIOSIGN PCP. This device is classified as a Enzyme Immunoassay, Phencyclidine.
Submitted by Princeton BioMeditech Corp. (Monmouth Junction, US). The FDA issued a Cleared decision on May 31, 1996, 59 days after receiving the submission on April 2, 1996.
This device falls under the Toxicology FDA review panel.
| 510(k) Number | K961266 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 02, 1996 |
| Decision Date | May 31, 1996 |
| Days to Decision | 59 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Statement |
| Product Code | LCM — Enzyme Immunoassay, Phencyclidine |
| Device Class | — |