The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Inc. with the FDA for Advia Centaur Intact Parathyroid Hormone (pth) Assay.
| Device ID | K163658 |
| 510k Number | K163658 |
| Device Name: | ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay |
| Classification | Radioimmunoassay, Parathyroid Hormone |
| Applicant | Siemens Healthcare Diagnostics Inc. 511 Benedict Avenue Tarrytown, NY 10591 |
| Contact | Darius Daruwala |
| Correspondent | Darius Daruwala Siemens Healthcare Diagnostics Inc. 511 Benedict Avenue Tarrytown, NY 10591 |
| Product Code | CEW |
| CFR Regulation Number | 862.1545 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-23 |
| Decision Date | 2017-05-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414599441 | K163658 | 000 |
| 00630414592404 | K163658 | 000 |
| 00630414592381 | K163658 | 000 |
| 00630414592350 | K163658 | 000 |
| 00630414592343 | K163658 | 000 |
| 00630414592336 | K163658 | 000 |
| 00630414599496 | K163658 | 000 |
| 00630414599489 | K163658 | 000 |