K161964 is an FDA 510(k) clearance for the ADVIA Centaur HAV IgM Assay. This device is classified as a Hepatitis A Test (antibody And Igm Antibody) (Class II - Special Controls, product code LOL).
Submitted by Siemens Healthcare Diagnostics, Inc. (Tarrytown, US). The FDA issued a Cleared decision on October 13, 2016, 87 days after receiving the submission on July 18, 2016.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3310.
| 510(k) Number | K161964 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 18, 2016 |
| Decision Date | October 13, 2016 |
| Days to Decision | 87 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 |