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 |