The following data is part of a premarket notification filed by Genalyte, Inc. with the FDA for Maverick Rnp Assay And Maverick Diagnostic System.
| Device ID | K191085 |
| 510k Number | K191085 |
| Device Name: | Maverick RNP Assay And Maverick Diagnostic System |
| Classification | Anti-rnp Antibody, Antigen And Control |
| Applicant | Genalyte, Inc. 10520 Wateridge Circle San Diego, CA 92121 |
| Contact | Rick Hockett |
| Correspondent | Rick Hockett Genalyte, Inc. 10520 Wateridge Circle San Diego, CA 92121 |
| Product Code | LKO |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-24 |
| Decision Date | 2019-10-25 |