The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics, Inc. with the FDA for Advia Centaur Cmv Igg And Advia Centaur Cmv Igg Quality Control.
| Device ID | K181213 |
| 510k Number | K181213 |
| Device Name: | ADVIA Centaur CMV IgG And ADVIA Centaur CMV IgG Quality Control |
| Classification | Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus |
| Applicant | Siemens Healthcare Diagnostics, Inc. 511 Benedict Ave Tarrytown, NY 10591 |
| Contact | Kira Gordon |
| Correspondent | Kira Gordon Siemens Healthcare Diagnostics, Inc. 511 Benedict Ave Tarrytown, NY 10591 |
| Product Code | LFZ |
| CFR Regulation Number | 866.3175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-07 |
| Decision Date | 2018-07-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414246635 | K181213 | 000 |
| 00630414246482 | K181213 | 000 |
| 00630414588872 | K181213 | 000 |
| 00630414587448 | K181213 | 000 |