The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Inc. with the FDA for Advia Centaur Havm Assay.
| Device ID | K081716 |
| 510k Number | K081716 |
| Device Name: | ADVIA CENTAUR HAVM ASSAY |
| Classification | Hepatitis A Test (antibody And Igm Antibody) |
| Applicant | Siemens Healthcare Diagnostics Inc. 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Contact | Mary Seeger |
| Correspondent | Mary Seeger Siemens Healthcare Diagnostics Inc. 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Product Code | LOL |
| CFR Regulation Number | 866.3310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-18 |
| Decision Date | 2008-07-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414597737 | K081716 | 000 |
| 00630414301259 | K081716 | 000 |