The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics, Inc. with the FDA for Advia Centaur Hav Igm Assay.
| Device ID | K161964 |
| 510k Number | K161964 |
| Device Name: | ADVIA Centaur HAV IgM Assay |
| Classification | Hepatitis A Test (antibody And Igm Antibody) |
| Applicant | Siemens Healthcare Diagnostics, Inc. 511 Benedict Avenue Tarrytown, NY 10591 |
| Contact | Philip Liu |
| Correspondent | Philip Liu Siemens Healthcare Diagnostics, Inc. 511 Benedict Avenue Tarrytown, NY 10591 |
| Product Code | LOL |
| CFR Regulation Number | 866.3310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-18 |
| Decision Date | 2016-10-13 |
| Summary: | summary |