K172471 is an FDA 510(k) clearance for the VENTANA CD30 (Ber-H2) RxDx Assay. This device is classified as a Lambda, Antigen, Antiserum, Control (Class II - Special Controls, product code DEH).
Submitted by Ventana Medical Systems, Inc. (Tucson, US). The FDA issued a Cleared decision on May 8, 2018, 266 days after receiving the submission on August 15, 2017.
This device falls under the Medical Genetics FDA review panel. Regulated under 21 CFR 866.5550.
| 510(k) Number | K172471 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 15, 2017 |
| Decision Date | May 08, 2018 |
| Days to Decision | 266 days |
| Submission Type | Traditional |
| Review Panel | Medical Genetics (MG) |
| Summary | Summary PDF |
| Product Code | DEH — Lambda, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5550 |