The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Inc. with the FDA for Advia Centaur Zika Test, Advia Centaur Zika Ab (100 Tests), Advia Centaur Zika Igm (50 Tests), Advia Centaur Zika Ab Quality Control, Advia Centaur Zika Igm Quality Control.
| Device ID | K191578 |
| 510k Number | K191578 |
| Device Name: | ADVIA Centaur Zika Test, ADVIA Centaur Zika Ab (100 Tests), ADVIA Centaur Zika IgM (50 Tests), ADVIA Centaur Zika Ab Quality Control, ADVIA Centaur Zika IgM Quality Control |
| Classification | Zika Virus Serological Reagents |
| Applicant | Siemens Healthcare Diagnostics Inc. 511 Benedict Avenue Tarrytown, NY 10591 |
| Contact | Matthew Gee |
| Correspondent | Matthew Gee Siemens Healthcare Diagnostics Inc. 511 Benedict Avenue Tarrytown, NY 10591 |
| Product Code | QFO |
| CFR Regulation Number | 866.3935 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-14 |
| Decision Date | 2019-07-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414286860 | K191578 | 000 |
| 00630414286853 | K191578 | 000 |
| 00630414286846 | K191578 | 000 |
| 00630414286839 | K191578 | 000 |
| 00630414247038 | K191578 | 000 |
| 00630414247021 | K191578 | 000 |
| 00630414247014 | K191578 | 000 |
| 00630414247007 | K191578 | 000 |