Submission Details
| 510(k) Number | K924751 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 23, 1992 |
| Decision Date | December 11, 1992 |
| Days to Decision | 79 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Statement |
K924751 is an FDA 510(k) clearance for the SOLARCARE TECHNOLOGIES CORP. MICRO-PLATE PCP ASSAY, a Enzyme Immunoassay, Phencyclidine, submitted by Solarcare Technologies Corp,Inc. (Bethlehem, US). The FDA issued a Cleared decision on December 11, 1992, 79 days after receiving the submission on September 23, 1992. This device falls under the Toxicology review panel.
| 510(k) Number | K924751 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 23, 1992 |
| Decision Date | December 11, 1992 |
| Days to Decision | 79 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Statement |
| Product Code | LCM — Enzyme Immunoassay, Phencyclidine |
| Device Class | — |