The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Inc. with the FDA for Advia Centaur Total Ige (tige).
| Device ID | K193493 |
| 510k Number | K193493 |
| Device Name: | ADVIA Centaur Total IgE (tIgE) |
| Classification | Ige, Antigen, Antiserum, Control |
| Applicant | Siemens Healthcare Diagnostics Inc. 511 Benedict Avenue Tarrytown, NY 10591 |
| Contact | Ian Thompson |
| Correspondent | Ian Thompson Siemens Healthcare Diagnostics Inc. 511 Benedict Avenue Tarrytown, NY 10591 |
| Product Code | DGC |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-17 |
| Decision Date | 2020-01-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414599397 | K193493 | 000 |
| 00630414599380 | K193493 | 000 |
| 00630414599373 | K193493 | 000 |
| 00630414177489 | K193493 | 000 |
| 00630414177472 | K193493 | 000 |