The following data is part of a premarket notification filed by Axis-shield Diagnostics Limited. with the FDA for Advia Centaur Anti-ccp Igg (accp) Assay Including Reagents And Calibrators, Quality Controls And Master Curve Materials..
| Device ID | K153551 |
| 510k Number | K153551 |
| Device Name: | ADVIA Centaur Anti-CCP IgG (aCCP) Assay Including Reagents And Calibrators, Quality Controls And Master Curve Materials. |
| Classification | Antibodies, Anti-cyclic Citrullinated Peptide (ccp) |
| Applicant | Axis-Shield Diagnostics Limited. The Technology Park Luna Place Dundee, GB Dd2 1xa |
| Contact | Claire I Dora |
| Correspondent | Claire I Dora Axis-Shield Diagnostics Limited. The Technology Park Luna Place Dundee, GB Dd2 1xa |
| Product Code | NHX |
| CFR Regulation Number | 866.5775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-11 |
| Decision Date | 2016-08-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414592312 | K153551 | 000 |
| 00630414245683 | K153551 | 000 |
| 00630414245676 | K153551 | 000 |
| 00630414245669 | K153551 | 000 |
| 00630414592329 | K153551 | 000 |
| 00630414592305 | K153551 | 000 |