The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Advia Centaur Inact Parathyroid Hormone (ipth) Assay.
| Device ID | K121981 |
| 510k Number | K121981 |
| Device Name: | ADVIA CENTAUR INACT PARATHYROID HORMONE (IPTH) ASSAY |
| Classification | Radioimmunoassay, Parathyroid Hormone |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS 511 Benedict Avenue Tarrytown, NY 10591 |
| Contact | Philip Liu |
| Correspondent | Philip Liu SIEMENS HEALTHCARE DIAGNOSTICS 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 | 2012-07-06 |
| Decision Date | 2013-03-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414585352 | K121981 | 000 |
| 00630414585345 | K121981 | 000 |