K935161 is an FDA 510(k) clearance for the KERATIN PRIMARY ANTIBODY. 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 March 22, 1996, 875 days after receiving the submission on October 29, 1993.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5550.
| 510(k) Number | K935161 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 29, 1993 |
| Decision Date | March 22, 1996 |
| Days to Decision | 875 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | DEH — Lambda, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5550 |