K190428 is an FDA 510(k) clearance for the Elecsys Anti-HAV II. This device is classified as a Hepatitis A Test (antibody And Igm Antibody) (Class II - Special Controls, product code LOL).
Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on August 13, 2019, 172 days after receiving the submission on February 22, 2019.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3310.
| 510(k) Number | K190428 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 22, 2019 |
| Decision Date | August 13, 2019 |
| Days to Decision | 172 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | LOL — Hepatitis A Test (antibody And Igm Antibody) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3310 |