K920566 is an FDA 510(k) clearance for the AEC DETECTION KIT. This device is classified as a Igm, Peroxidase, Antigen, Antiserum, Control (Class II - Special Controls, product code DEY).
Submitted by Ventana Medical Systems, Inc. (Tucson, US). The FDA issued a Cleared decision on May 8, 1992, 91 days after receiving the submission on February 7, 1992.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5550.
| 510(k) Number | K920566 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 07, 1992 |
| Decision Date | May 08, 1992 |
| Days to Decision | 91 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | DEY — Igm, Peroxidase, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5550 |