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 |