K924578 is an FDA 510(k) clearance for the PSA ANTIBODY KIT. This device is classified as a Kappa, Peroxidase, Antigen, Antiserum, Control (Class II - Special Controls, product code DFD).
Submitted by Ventana Medical Systems, Inc. (Tucson, US). The FDA issued a Cleared decision on February 5, 1993, 148 days after receiving the submission on September 10, 1992.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5550.
| 510(k) Number | K924578 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 10, 1992 |
| Decision Date | February 05, 1993 |
| Days to Decision | 148 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | DFD — Kappa, Peroxidase, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5550 |