K220163 is an FDA 510(k) clearance for the Her-2, ER, PR IHControls. This device is classified as a Control Material, Her-2/neu, Immunohistochemistry (Class II - Special Controls, product code NJW).
Submitted by Boston Cell Standards, Inc. (Sharon, US). The FDA issued a Cleared decision on August 15, 2022, 207 days after receiving the submission on January 20, 2022.
This device falls under the Pathology FDA review panel. Regulated under 21 CFR 864.1860. Accessory To Immunohistochemistry Assays For Her2-neu. Control Material Intended For Laboratory Use To Control Her2-neu Immunohistochemistry Assays..
| 510(k) Number | K220163 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 20, 2022 |
| Decision Date | August 15, 2022 |
| Days to Decision | 207 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | Summary PDF |
| Product Code | NJW - Control Material, Her-2/neu, Immunohistochemistry |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.1860 |
| Definition | Accessory To Immunohistochemistry Assays For Her2-neu. Control Material Intended For Laboratory Use To Control Her2-neu Immunohistochemistry Assays. |