The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Inc. with the FDA for Advia Centaur Intact Parathyroid Hormone (ipth) Assay.
| Device ID | K133601 |
| 510k Number | K133601 |
| Device Name: | ADVIA CENTAUR INTACT PARATHYROID HORMONE (IPTH) ASSAY |
| Classification | Radioimmunoassay, Parathyroid Hormone |
| Applicant | Siemens Healthcare Diagnostics Inc. 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Contact | Philip Liu |
| Correspondent | Philip Liu Siemens Healthcare Diagnostics Inc. 511 BENEDICT AVE. 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 | 2013-11-25 |
| Decision Date | 2014-02-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414579160 | K133601 | 000 |
| 00630414579153 | K133601 | 000 |