K191085 is an FDA 510(k) clearance for the Maverick RNP Assay and Maverick Diagnostic System. This device is classified as a Anti-rnp Antibody, Antigen And Control (Class II - Special Controls, product code LKO).
Submitted by Genalyte, Inc. (San Diego, US). The FDA issued a Cleared decision on October 25, 2019, 184 days after receiving the submission on April 24, 2019.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5100.
| 510(k) Number | K191085 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 24, 2019 |
| Decision Date | October 25, 2019 |
| Days to Decision | 184 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | LKO - Anti-rnp Antibody, Antigen And Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5100 |