The following data is part of a premarket notification filed by Axis-shield Diagnostics Limited with the FDA for Advia Centaur Calcitonin (calct) Assay.
| Device ID | K182012 |
| 510k Number | K182012 |
| Device Name: | ADVIA Centaur Calcitonin (CALCT) Assay |
| Classification | Radioimmunoassay, Calcitonin |
| Applicant | Axis-Shield Diagnostics Limited Luna Place, The Technology Park Dundee, GB Dd2 1xa |
| Contact | Claire Dora |
| Correspondent | Claire Dora Axis-Shield Diagnostics Limited Luna Place, The Technology Park Dundee, GB Dd2 1xa |
| Product Code | JKR |
| CFR Regulation Number | 862.1140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-27 |
| Decision Date | 2018-12-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414284743 | K182012 | 000 |
| 00630414284736 | K182012 | 000 |